Nigel Crossland looks at the issues of bad science and its practice as applied to healthcare in both laboratory and clinical settings.
Good scientific practices help ensure that work is valid, correct and that misinterpretation, exaggeration, bias and falsification are prevented.
Bad science in medicine, if permitted, can lead to misdiagnosis, incorrect treatment, incorrect dosage, failure to see and record clinical changes (positive or negative), or draw unjustified study conclusions. In the research and development of new drugs, medical devices, biosynthetic materials or tissue-engineered products, good scientific practice within clinical or laboratory settings is based on the application of international quality assurance standards supported in the EU by comprehensive legal requirements.
All professional bodies and individuals undertaking research involving human subjects are required to follow good scientific practice, including adherence to the ethical principles that have their origin in the Declaration of Helsinki.
Good scientific practice in analytical laboratories encompasses a set of principles that provides a framework within which laboratory testing and sample analyses are planned, performed, controlled, recorded, confirmed and reported, says the World Health Organization.
The analytical facilities should be of proper design with management systems, equipment maintenance with back-up, and a validated system for both internal and external quality control. All technical staff should be suitably qualified and trained and there should be a comprehensive collection of standard operating procedures.
Pseudo science and quackery
Moving forward now to the consequences of bad science – the deliberate promotion and provision of materials and treatment of subjects, supported using false claims, while ignoring scientific evidence that such treatment is either no better than placebo or is actually harmful, is bad scientific practice. In many contexts, such conduct is classified as pseudo science or quackery.
There are many examples of this stretching through history, from the painting Marriage a-la mode – The Inspection by William Hogarth, 1743; through to the 20th century, where in the 1930s drinking of radioactive water was promoted (Radium Laboratories, New Jersey: “It was fine until his jaw dropped off ”).
In the 21st century, we still see plenty of evidence of people advocating potions and elixirs which have absolutely no scientific evidence to support their usage. While these, unlike the radioactive preparations, may not cause any harm, the absence of effective therapy during the course of an illness is likely to lead to appreciable worsening of the problem.
More recently, a case involving questionable and deficient medical research was identified by retraction of the original medical publication in The Lancet. This included a statement of refutation by the journal’s editor and involvement by the General Medical Council. This is the case of the combined measles, mumps, and rubella (MMR) vaccine debacle.
The case involved a medical practitioner who undertook a research study involving young children and attempted to prove a link between the vaccine and autism or bowel disease. The controversy started with the 1998 publication of a research paper in the medical journal The Lancet, supporting the later discredited claim that colitis and autism spectrum disorders are linked to the MMR vaccine.
Aspects of the media coverage were also criticised for naïve reporting and lending undue credibility to the physician responsible for the fl awed study, Dr Andrew Wakefield. Subsequent accredited studies in the last eight years have found no link between the vaccine and autism or bowel disease.
Study deficiencies included undeclared conflicts of interest, as well as manipulated evidence and the treatment of child trial subjects not in adherence to the relevant ethical codes. Following an investigation by the General Medical Council, Dr Wakefield was found to have committed serious professional misconduct and was removed from the medical register.
The consequences
A more current example is the case of transplant surgery for patients with damaged tracheas, using a novel biosynthetic restructuring procedure involving stem cells. Published details describe the process whereby new tracheal tissue is “grown” quickly, safely and bio-matched for each patient.
The project was centred at the prestigious Karolinska Institute, Sweden, with the study performed at various satellite hospitals. The responsible study physician was thoracic surgeon Dr Paolo Macchiarini.
It was later revealed in the journal Nature that he had falsified his CV. Of the nine patients who received the treatment over the course of five years, seven have died. The two who are still alive are reported to have had their synthetic transplants removed and replaced with tracheas from donors.
The consequences of investigations conducted into this affair have been far-reaching and damaging for not only Dr Macchiarini but also the institute itself, which failed to ensure that relevant scientific and ethical standards were being applied at all stages of the study.
Besides Dr Macchiarini, several senior personnel have either been dismissed or have resigned from their positions at the institute over this case. In September last year, the Swedish government moved to dismiss the entire board of the institute. The institute’s Vice Chancellor Dr Anders Hamsten was also removed from his role on the Nobel Prize for Medicine, which is additionally overseen by the institute.
These studies, which are illustrative of bad scientific practices, were reliant upon preconceived beliefs of research outcomes and ignored patient welfare. Falsification, bias and an absence of adequate ethical practice brought the respective lead physicians to the attention of governing bodies where in one case investigations are still ongoing.
Nigel Crossland is an Independent Pharmaceutical Scientist and Consultant.