PRESS-NEWS.org - Press Release Distribution
PRESS RELEASES DISTRIBUTION

Were clinical trial practices in East Germany questionable?

Drug firms took advantage of East Germany's financial problems to carry out trials with ethically uncertain processes, say researchers

2014-10-24
(Press-News.org) Clinical trials carried out in the former East Germany in the second half of the 20th century were not always with the full knowledge or understanding of participants with some questionable practices taking place, according to a paper published online in the Journal of Medical Ethics. Moreover, the country agreed to the trials due to impending bankruptcy there and Western pharmaceutical companies took advantage of the situation, said researchers who have studied documents from the time.

The German Democratic Republic (GDR), known as East Germany, was a state within the Eastern Bloc during the Cold War period and between 1949 and 1990, it administered the part of Germany that was occupied by Soviet forces at the end of World War II.

Since the 1990s, the media has reported unofficial clinical trials were conducted by Western pharmaceutical companies in Eastern Germany from the 1960s onwards, and a similarly themed article published in 2013 in the German news magazine Der Spiegel brought international attention to the claims.

Claims were made that the German Democratic Republic (GDR) had 'sold' its patients as 'guinea pigs' for experiments in exchange for hard currency, for example, for tests on doping effects in premature babies and on treating seriously ill patients with placebo instead of actual medicine.

However, there is still a lack of reliable data about the extent of studies taking place then, the contracts, the amount of money paid, and more moral issues such as patient education and informed consent.

German researchers, therefore, set out to bring a more scientific and objective account of these trials by describing and evaluating the clinical trials performed in the GDR based on archival material from the health system and the secret service.

They found documents relating to 220 trials carried out between 1983 and 1990 involving more than 14,000 patients and 68 Western companies.

There was, however, no record of patient information forms or systematic documentation regarding the provision of patient consent.

A range of drugs was tested in these studies, including chemotherapeutic agents, insulin, heparin, anti-depressants, anti-allergy drugs, as well as contrast agents and toothpastes.

Hundreds of patients were involved in clinical trials of cardiovascular drugs, which were among the most expensive studies and resulted in a number of deaths, probably due to the fact that an inclusion criterion for participants in some of these double-blind studies was the presence of a severe New York Heart Association class III–IV heart condition.

Between 1983 and 1990, the country's health system received approximately DM 16.5 million for the clinical trials, which were cost effective for the drug firms and which they capitalised on, said the researchers.

Despite some strict legal regulations, the state was obliging due to its desperate need for hard currency so companies were able to legally test new drugs, while at the same time opening up new markets in the Eastern Bloc and getting test results faster and more cheaply than they could elsewhere.

The researchers found that overall, the files they studied suggested that the GDR attempted to conduct trials according to international ethical standards and there was no evidence to suggest the trials systematically and intentionally damaged patients.

These trials were, however, conducted without the knowledge of the public, and state legislation stipulated that patients had to consent to the trials, but no evidence was found to suggest that patients were systematically informed.

Some documents suggested that at least some of the trials were carried out without patients having a comprehensive understanding of what the trial involved and it was unclear whether the patients themselves knew that they were participating in trials and were aware of all risks.

Further investigation of any ethical violation during these trials was needed, concluded the authors, who said: "In this case, media sensationalisation of the trials seems unjustified: the reports were tendentious, distorted and, in many cases incorrect.

"We need reliable results and objective investigation in order to deepen our historical and ethical understanding. Currently, there is very little independent research on the GDR healthcare system of the 1980s. Specific trials now need to be studied separately."

INFORMATION:



ELSE PRESS RELEASES FROM THIS DATE:

The Lancet: The hidden truth about the health of homeless people

2014-10-24
As many as 4 million Europeans and 3.5 million Americans experience homelessness every year, and the numbers are rising. Homeless people 'are the sickest in our society,' but just treating ill health might not be enough to help get people off the streets, according to a new two-part series on homelessness in high-income countries, published in The Lancet. The Series highlights that being homeless is not only bad for your physical and mental health but also has dramatic effects on life expectancy [Paper 1]. Rates of tuberculosis infection, for example, are at least 20 ...

The Lancet Infectious Diseases: Study predicts that current international commitments will not contain Ebola outbreak in Montserrado, Liberia

2014-10-24
New modeling research, published in The Lancet Infectious Diseases journal, has found that the number of Ebola treatment center beds and other measures needed to control the epidemic in Montserrado County, Liberia substantially exceeds the total pledged by the international community to date. The research shows that, without expanded control efforts, up to 170996 total reported and unreported Ebola cases, and 90122 deaths are projected in Montserrado by 15 December, 2014. The study estimates that of these, 42669 cases and 27175 deaths will have been reported by that time. However, ...

Without swift influx of substantial aid, Ebola epidemic in Africa poised to explode

2014-10-24
The Ebola virus disease epidemic already devastating swaths of West Africa will likely get far worse in the coming weeks and months unless international commitments are significantly and immediately increased, new research led by Yale researchers predicts. The findings are published online first in The Lancet Infectious Diseases. A team of seven scientists from Yale's Schools of Public Health and Medicine and the Ministry of Health and Social Welfare in Liberia developed a mathematical transmission model of the viral disease and applied it to Liberia's most populous ...

Treating ill health might not be enough to help homeless people get off the streets

Treating ill health might not be enough to help homeless people get off the streets
2014-10-24
TORONTO, Oct. 24, 2014—Health care providers should recognize that any effective strategy to address homelessness needs to include both interventions to improve the health of homeless individuals as well as larger-scale policy changes, according to a paper published today. "It is essential to recognize that homelessness is equally the result of structural factors within a society, such as systematic inequities in educational and employment opportunities, a shortage of affordable housing, and social policies that are targeted against marginalized populations," said ...

People who develop kidney stones may face increased bone fracture risk

2014-10-24
Washington, DC (October 23, 2014) — People who develop kidney stones may be at increased risk of experiencing bone fractures, according to a study appearing in an upcoming issue of the Clinical Journal of the American Society of Nephrology (CJASN). The findings suggest that preventive efforts may be needed to help protect stone formers' bone health. People who form stones in the kidneys and urinary tract—a condition called urolithiasis—may have reduced bone mineral density and an increased risk of bone fractures. To assess the link between urolithiasis ...

Costs to treat bleeding strokes increases 10 years later

2014-10-23
Costs to treat strokes caused by bleeding in the brain may increase significantly 10 years later, according to a study in the American Heart Association journal Stroke. The Australian study is the first to include 10 years of follow-up data on stroke cost estimates, which may also apply to the United States, researchers said. Generally, expenses associated with a stroke peak within the first year and decline over time. Previous estimates of lifetime costs in Australia were based on a five-year average and may have underestimated costs, specifically for hemorrhagic (bleeding) ...

Progression of age-related macular degeneration in one eye then fellow eye

2014-10-23
Having age-related macular degeneration (AMD) in one eye was associated with an increased incidence of AMD and accelerated progression of the debilitating disease in the other eye, writes author Ronald E. Gangnon, Ph.D., of the University of Wisconsin School of Medicine and Public Health, Madison, and colleagues. AMD is thought to be a symmetric disease, although one eye may precede the other in progression. The authors examined the effect of severity of AMD in one eye on the incidence, progression and regression in the other eye. Data from 4,379 participants in the ...

Pre-enlistment mental disorders and suicidality among new US Army soldiers

2014-10-23
Two new studies suggest that while individuals enrolling in the armed forces do not share the exact psychological profile as socio-demographically comparable civilians, they are more similar than previously thought. The first study found that new soldiers and matched civilians are equally likely to have experienced at least one major episode of mental illness in their lifetime (38.7 percent of new soldiers; 36.5 percent of civilians) but that some mental disorders (generalized anxiety disorder, post-traumatic stress disorder and conduct disorder) are more common among ...

NASA HS3 mission Global Hawk's bullseye in Hurricane Edouard

NASA HS3 mission Global Hawks bullseye in Hurricane Edouard
2014-10-23
NASA's Hurricane Severe Storms Sentinel or HS3 mission flew the unmanned Global Hawk aircraft on two missions between Sept. 11 and 15 into Hurricane Edouard and scored a bullseye by gathering information in the eye of the strengthening storm. Scientists saw how upper-level wind shear was affecting Edouard on the HS3's Global Hawk flight of the 2014 campaign over Sept. 11 and 12, and saw the hurricane strengthen during the sixth flight on Sept. 15 and 16. NASA's HS3 mission returned to NASA's Wallops Flight Facility, in Wallops Island Virginia for the third year to investigate ...

Nation's 'personality' influences its environmental stewardship, shows new study

2014-10-23
Toronto – Countries with higher levels of compassion and openness score better when it comes to environmental sustainability, says research from the University of Toronto. A new study by Jacob Hirsh, an Assistant Professor of Organizational Behaviour & Human Resource Management at the University of Toronto Mississauga's Institute for Management & Innovation, who is cross-appointed to UofT's Rotman School of Management, demonstrates that a country's personality profile can predict its environmental sustainability records. While Prof. Hirsh's previous work has ...

LAST 30 PRESS RELEASES:

Genetic causes of cerebral palsy uncovered through whole-genome sequencing

Modesty and boastfulness – perception depends on usual performance

Do sweeteners increase your appetite? New evidence from randomised controlled trial says no 

Women with obesity do not need to gain weight during pregnancy, new study suggests

Individuals with multiple sclerosis face substantially greater risk of hospitalisation and death from COVID-19, despite high rates of vaccination

Study shows obesity in childhood associated with a more than doubling of risk of developing multiple sclerosis in early adulthood

Rice Emerging Scholars Program receives $2.5M NSF grant to boost STEM education

Virtual rehabilitation provides benefits for stroke recovery

Generative AI develops potential new drugs for antibiotic-resistant bacteria

Biofuels could help island nations survive a global catastrophe, study suggests

NJIT research team discovering how fluids behave in nanopores with NSF grant

New study shows association of historical housing discrimination and shortfalls in colon cancer treatment

Social media use may help to empower plastic surgery patients

Q&A: How to train AI when you don't have enough data

Wayne State University researchers uncover potential treatment targets for Zika virus-related eye abnormalities

Discovering Van Gogh in the wild: scientists unveil a new gecko species

Small birds spice up the already diverse diet of spotted hyenas in Namibia

Imaging detects transient “hypoxic pockets” in the mouse brain

Dissolved organic matter could be used to track and improve the health of freshwaters

Indoor air quality standards in public buildings would boost health and economy, say international experts

Positive associations between premenstrual disorders and perinatal depression

New imaging method illuminates oxygen's journey in the brain

Researchers discover key gene for toxic alkaloid in barley

New approach to monitoring freshwater quality can identify sources of pollution, and predict their effects

Bidirectional link between premenstrual disorders and perinatal depression

Cell division quality control ‘stopwatch’ uncovered

Vaccine protects cattle from bovine tuberculosis, may eliminate disease

Andrew Siemion to receive the SETI Institute’s 2024 Drake Award

New study shows how the Crimean-Congo hemorrhagic fever virus enters our cells

Neoadjuvant chemotherapy proves effective for locally advanced penile squamous cell carcinoma

[Press-News.org] Were clinical trial practices in East Germany questionable?
Drug firms took advantage of East Germany's financial problems to carry out trials with ethically uncertain processes, say researchers