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As part of his closing remarks at the 2022 edition of the International Union of Toxicology (IUTOX) and EUROTOX co-sponsored Risk Assessment Summer School (RASS), world renowned toxicologist, risk assessment expert and academician, Prof. Corrado Lodovico Galli emphasised the importance of integrity in the practice of toxicology, and more specifically in risk assessment. As a toxicologist involved in risk assessment and more specifically in the derivation of Health Based Exposure Limits (HBELs), specifically Permitted Daily Exposures (PDE) of medicinal products, I took his words seriously and started wondering how best this could be taken into account in the selection and engagement of experts to do these derivations for pharmaceutical industries. This comes in the wake of numerous "experts" in the industry who are producing shoddy, low quality reports and monographs which could put the health of the public at risk. In this short opinion paper, I argue that engaging a toxicologist who is certified and or belongs to a professional toxicology society may be a way of avoiding the engagement of charlatans in the industry.
The derivation of PDE for the pharmaceutical industry according to all the major guidances requires a qualified expert who would ordinarily be a toxicologist. The definition of such a person is almost equivocal across the board.
According to both European Medicines Agency (EMA) and the Pharmaceutical Inspectorate Cooperation Scheme (PIC/S), "Health-Based Exposure Limits should be determined by a person who has adequate expertise and experience in toxicology/pharmacology, familiarity with pharmaceuticals as well as experience in the determination of health-based exposure limits such as Occupational Exposure Levels (OEL) or Permitted Daily Exposure (PDE)." (1,2)
The World Health Organisation (WHO) in its draft working document states that, "Data and information should be gathered by a person with appropriate qualifications and experience in the field of toxicology and/or pharmacology." (3)
The American Society for Testing and Materials (ASTM) defines a qualified expert as an, "Individual with specific education and training in toxicology/pharmacology/ pharmacotherapy and risk assessment methods that can apply the principles of toxicology to deriving an HBEL." (4)
A look at all the definitions (and their nuances) above will demonstrate an obvious skew towards educational (and training) qualifications and experience in the field with no direct reference to issues of integrity, ethics or accountability on the part of the expert toxicologist. Whilst academic qualifications, training and experience, to some extent, do give solace that an organisation has engaged someone who knows what he or she is doing, they may not speak much to issues of integrity and ethical conduct of the toxicologist. What happens if you hire a charlatan? Who do you report such a person to?
In my opinion, this is where the value a recognised certification/licensure/registration as well as belonging to a professional toxicology society comes becomes an important piece of the 'hiring an expert puzzle'. Whilst not guaranteeing that a qualified expert belonging to the aforementioned will act professionally and with integrity, there can some comfort on the part of those who engage them that should they be incompetent or unethical, there is a place or body where they can be held to account. This is because such registers and associations are normally governed by codes of ethics which its members are expected to adhere to and in most cases these would include issues to do with integrity, competence and or excellence in professional conduct. Thus in my opinion, no serious toxicologist would want to be expelled from a professional register and or a society e.g., the Society of Toxicology on the basis on unethical or incompetent conduct. My main argument in this short article is therefore that in addition to the qualifications and experience stated in the various guidances (1-4), it may be prudent for companies hiring experts to ensure that they belong to some register and or society where they (the experts) are accountable and expected to adhere to defined ethical and professional practice norms. Although section 5.2 of the ASMT guideline 3219-20 does specifically mention issues of certification (4), I feel that the value of certifications such as the Diplomate of the American Board of Toxicology (DABT) (5) or the European Registered Toxicologist (ERT) (6) is overly down played in the guidances mentioned above. Whilst belonging to a professional register may not guarantee that the toxicologist is an expert in risk assessment, it does however to a large extent certify the competence, qualifications and experience of the toxicologist. But perhaps more importantly, it also speaks of the value that the expert holds on ethical and professional norms expected of the professional - and by extension issues of integrity that the good professor Galli was talking about.
Concerning membership to professional associations, Olson and colleagues in their recent paper (7) when addressing the issue of a qualified HBEL expert stated that, "In addition to industry accepted toxicology credentials and certifications, membership and participation in professional toxicology societies may be considered advantageous." The authors saw the value of membership and participation in professional toxicology as being advantageous, and I could not agree any less.
Therefore in conclusion, whilst qualifications, training and experience are key in ensuring that companies engage HBEL toxicology experts who know what they are doing, the value of certifications as well as belonging to professional toxicology societies should not be taken for granted since this also brings into play issues of integrity and ethical conduct.
(This article was published on LinkedIn URL: https://www.linkedin.com/pulse/engaging-pde-expert-toxicologist-value-certification-dexter?trk=public_post)
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