Posted on 05/25/2010 12:14:55 PM PDT by decimon
How patients are harmed by the concealment of knowledge
This release is available in German.
No one knows how many mothers' and babies' lives have been saved by the obstetrical forceps. This device has been part of the standard equipment of every maternity room for about 250 years. However, a shadow lies over the success story: after the Chamberlen brothers developed the device at the beginning of the 17th century, the brothers and their descendants used it for 3 generations, but kept it a secret from other obstetricians. While thanks to the forceps the Chamberlen family became rich and famous, at the same time women and babies were still dying elsewhere because the device was not available.
The story of the obstetrical forceps is one of the oldest documented examples showing what consequences secrecy in medicine can have. In an article published in the journal Trials, researchers at the German Institute for Quality and Efficiency in Health Care (IQWiG) compiled over 60 examples illustrating how the dissemination of medical knowledge has been impeded. For this purpose, they assessed hundreds of articles from journals and other sources, which covered areas including treatment for psychiatric disorders, pain, heart and circulatory disease, skin disease, cancer, and infectious diseases. A wide range of interventions was affected: from drugs and vaccines to medical devices such as ultrasound or devices for wound care. The collection reads like the script for a crime series.
Concealment is common
In science the phenomenon is called "publication bias", i.e. bias through selective publication. This occurs on two levels: On the first level complete studies remain unpublished. For example, an analysis of 90 drugs that had been newly approved in the US showed that they had been tested in a total of 900 trials. However, even 5 years after approval, 60% of these studies were unpublished. On the second level only selected outcomes from studies are published. Nowadays researchers have to specify in a study protocol which outcomes they want to measure and how they are going to analyse them. Comparisons of protocols and journal articles of studies showed that in 40% to 60% of studies, results had either been completely omitted or analyses changed. "In this way study results are often presented in a more positive way than is actually the case," says Beate Wieseler, Deputy Head of IQWiG's Drug Assessment Department.
This does not only affect studies sponsored by the pharmaceutical industry. In their paper, the IQWiG authors also cite an analysis in which 2000 studies on cancer topics were analysed according to sponsorship. The proportion of published studies was extremely low: of the industry-sponsored studies, 94% were unpublished; however, even 86% of university-sponsored studies were also unpublished. "Due to legal regulations, regulatory authorities are also sometimes obliged to withhold data," says Thomas Kaiser, Head of the Drug Assessment Department.
Patients are harmed
The concealment of knowledge often has consequences for patients. On the one hand, it can result in delays to the implementation and dissemination of beneficial interventions (as was the case with the obstetrical forceps). However, it is more common that bad news and reports of failure remain unpublished. "As a result, physicians and patients use treatments that are actually futile or even harmful," says Beate Wieseler. For example, researchers estimate that drugs prescribed in the 1980s to prevent irregular heart beat cost tens of thousands of lives, because early signs of dangerous adverse effects were not published.
Appeals are insufficient
IQWiG's search for documented examples of publication bias was triggered by the Institute's own experience in its daily work, as was recently the case, for example, in the assessment of reboxetine, a drug used to treat depression: the pharmaceutical company Pfizer only provided previously concealed studies to IQWiG after subjection to public pressure. In the previously unpublished studies, the results for reboxetine were considerably worse than appeared to be the case in published studies. "For many years, not only patients but also physicians have been deceived," says Beate Wieseler.
The collection of examples published in Trials shows that the tendency to conceal unfavourable results or results that do not fulfil one's own expectations is so widespread that appeals and proposals for voluntary solutions will not be able to solve the problem effectively. "The increasing registration of studies in public registries is an important first step," says Thomas Kaiser. "However, in order to protect patients, we need legal regulations, so that results of all clinical trials are published swiftly and completely."
Ping
So... inventions must immediately become public property, for the common good? How progressive. Must be an Obamanoid idea.
While I agree that the medical community has an ethical obligation to make lifesaving technology available for use by other doctors, this does have the ring of supporting government healthcare (after all, the government would ensure that such things were never withheld from patients, wouldn’t they? /s)
That’s not the impression I got reading the article. It is true that useful knowledge that is withheld form folks that could otherwise help them, harms people. That’s just a statement of fact. Even the Bible stresses the importance of knowledge: “My people are destroyed for a lack of knowledge.” Secular: Knowledge is Power.
The question you raise is a totally different question, one of morals and ethics and “should this be required?”. Different animal entirely.
I read about an 18th century doctor who was allowed to do an experiment where all the doctors in a maternity ward simply washed their hands. All kinds of complications dropped significantly.
His evidence was ignored and doctors continued working with grubby hands for another 75 years. The poor guy went mad trying to convince his colleagues he was right.
“Semmelweis’s colleagues treated his findings with hostility and he eventually resigned his position. It was not until after his death that others such as Louis Pasteur and Oliver Wendell Holmes recognised the importance of his work”
The real problem was that the germ theory of disease was not really formulated until the 1890’s (Pasteur, Kosh, etc), and so, Semmelweiss’ contemporaries did not really have the intellectual ability to appreciate his genius.
The story of Koch’s presentation of his work on cholera, and later, his postulates (1890) is illustrative of the problems that these early scientists faced at the dawn of the period of modern medicine.
His colleagues were presented with scientific fact that it worked. They shouldn’t have needed to understand WHY it worked. didn’t need to understand why.
But I don’t want to be too critical. The episode demonstrates a nasty side of human nature.
It seems inconceivable that WASHING your hands was once considered controversial.
I’m glad they have the vacumn to use now.
The problem was that the concept of scientific empiricism was not yet firmly established in the culture.
They did not yet have the intellectual foundations to understand and embrace the scientific method.
So for example, they knew that syphilis followed sexual contact, but it took awhile to for them to grasp that “sin” and “impurity” were not the cause of syphilis, rather that sin and impurity, via sexual contact, was the means of transmission of the causative agent of syphilis, the bacteria Treponema pallidum.
Koch, Pasteur, and others of their ilk were way ahead of their time.
This was written by the Insitute for Health Quality in GERMANY!! So you’re right. Why is this being posted here?
thanks decimon
“the pharmaceutical company Pfizer only provided previously concealed studies to IQWiG after subjection to public pressure. In the previously unpublished studies, the results for reboxetine were considerably worse than appeared to be the case in published studies. “For many years, not only patients but also physicians have been deceived”
This sort of thing is rampant in BIG PHARMA, and the FDA condones it. This lying, cover-up SOP should be punished severely, with prison time for BIG PHARMA execs and FDA execs. In some cases, where deaths occur among the public harmed by such drugs, murder charges should be brought - against drug execs and FDA.
Where is your /sarc tag?
My mother begged the obstetrician to use forceps when I was delivering my first child and the doctor just waved her aside.
My son was delivered with vacuum extraction.
The first time the doctor tried the vacuum, the handle broke off.
The second time, the baby was pulled out.
His head was shaped like a dixie cup for the first day.
I was delivered with forceps - that was in 1935
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