We strongly disagree with the title above – however, this statement is borrowed from a recent post on Medical Republic.
While we, the scientific community, are debating on what defines reproducibility vs replicability vs repeatability and about further important specifications, there are people who are following our activities closely and who make their own conclusions. To cite this Medical Republic post further:
“His words [referring to the statement in the title above] have been nibbling around the edges of my mind for the past six months. Surely, more than 115 million animals per year, billions of dollars, and entire careers can’t have been wasted on a faulty model?”
We have already heard about billions of dollars lost due to the lack of research quality (Freedman et al., 2015), but it was published by a scientist in a scientific journal and might have missed the tax payers attention. However, that the non-scientist community is now engaging in discussions about millions of animals wasted in non-reproducible research is a clear alarm signal and our inability to deal with the current challenges is starting to take its toll:
In a recent paper entitled “Human Stakeholders and the Use of Animals in Drug Development” that appeared in Business and Society Review (sic!), there is a very bold and clear proposal:
“… the U.S. Food and Drug Administration (FDA) and Congress should work together to abolish regulations and policies that require animal use.”
As the basis for such proposal, the authors write: “We cite hundreds of biomedical studies from journals including Nature, Science, and the Journal of the American Medical Association to show animal modeling is ineffective, misleading to scientists, unable to prevent the development of dangerous drugs, and prone to prevent the development of useful drugs.”
In some countries, such proposals are already supported by government members who develop national programs to become animal research-free within 10 years or less (e.g. in the Netherlands).
While we do support the 3R principles and should make every effort to minimize or avoid the use of animals in research, we are not ready yet to give up on the current methods to establish safety and efficacy of novel treatments that are advanced from preclinical research into clinical development.
Therefore, it becomes urgent and imperative to STOP bad quality research and support all efforts to enhance research quality, no matter how burdensome and aversive the term “quality” or “quality management” may appear to some scientists and science administrators.
Here at PAASP, we are very glad to be part of the EQIPD consortium – a very significant effort that could make a real difference in securing the quality of future drug development research!