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Why Am I Such a Jerk? February 2, 2012

Posted by Titus Quinctius Cincinnatus in Uncategorized.

A lot of readers probably wonder why I’m such a jerk.  Why is it that, instead of automatically believing the “Hephzibah Haters” and engaging in the daily ritual two minute hate against Hephzibah House, I actually defend them against unproven accusations?  How can I be such a meanie?  Don’t I realise how unpopular this makes me in some circles?  Wouldn’t it be so much easier for me to get on board the bandwagon and join in the chorus of cacophony against them?

Well, as I’ve intimated before, believing in the scriptural principle of requiring evidence before a witness is believed has a lot to do with it.  So does a commitment to the legal principle of “innocent until proven guilty.”  Ultimately, the latter derives from the former.

It strikes me, though, that there’s another reason why I don’t accept accusations without evidence.  It goes back to my training as a scientist and my employment in the pharmaceutical industry.

The reader may or may not be aware, but the pharmaceutical industry is one of the most heavily regulated industries in America.   Once you reach the stages in bringing a new drug through the pipeline where you are operating under the full cGMP regimen, pretty much everything done by anybody in the process – manufacturing personnel, contract analysts, support personnel, maintenance crews, and everyone else – is recorded, verified, confirmed, and committed to records for at least a decade.  Unlike most government regulation, I tend to not have a problem with the cGMP requirements enforced on the industry.  While there will always be mistakes that make it through, FDA regulation has actually helped to force the pharmaceutical industry to establish procedures that avoid the shoddiness and dangerous practices that existed far too often in the manufacture of drugs prior to the 1960s. 

Implicit in the cGMP process is the honesty of those involved.  When an analyst or manufacturing tech records a reading, writes down what they did in a labbook, fills in a batch record, or otherwise makes a written observation about something at some point in the myriad of steps involved in the process of preparing drugs for human consumption from start to finish, the expectation is there that they are providing accurate and truthful information.  The FDA takes a very dim view of people who purposefully obscure or invent data for any reason (laziness, pressure to cover up bad results, or whatever else).  The FDA even has a list of people debarred from participating in the industry, most of them permanently so.  Yet, the reason why there is so much regulation in the process is that this helps to buttress the demand for honest, as well as providing a way for innocent errors, accidental entries, etc, to be caught and corrected before they contribute to worse problems down the line.  In short, the pharmaceutical industry is very much a “trust, but verify” sort of environment.  The people who are employed in it are professionals and are assumed to be honest, faithful participants until proven otherwise, but controls are in place to catch errors, either accidental or purposeful.

This sort of regimen, when you operate under it day by day for years on end, helps to share your mindset.  This is, I think, part of why I do not accept the accusations against Hephzibah House without evidence or proof.

Let’s take an example – in the industry, every entry into a batch record has to be verified by another operator, either at the time of the operation being performed, or shortly thereafter (for less critical operations).  So, if an operator is instructed by a batch record to take a pH reading of a sample, then the operator records this pH, and another worker in the area verifies the reading and the entry.  There has to be visual confirmation of the reading. 

Likewise, there should be some sort of evidentiary proof that abuse has actually taken place before the accusation is accepted.  It should not be enough to simply take the word of the one making the accusation.  Indeed, in this case, there is none.  At the times where outside investigators have come in to check on HH, often at the instigation of a former student, nothing has been found. 

When an analytical chemist performs an experiment using some instrument, the chemist not only simply says that they have done so, but also has to provide graphical raw data in the form of chromatograms, electropherograms, spectra, or whatever other type of output the instrument provides.  This data is going to be timestamped, a record of where on the computer’s hard drive or network the data is located, and will typically be what is called “Part 11 compliant,” referring to a section in the FDA regulations governing the ineradicability of computerized records and electronic signatures (i.e. you can’t alter the data).   This data is then confirmed by a co-signer in the analyst’s notebook who verifies that the data meets all the standards and is legitimate.

Similarly, when an accusations are made, such as the ones against Hephzibah House, there should be an investigation made into the validity of the claims, and if they are to be accepted, then they should meet standards of factuality that can be proven.  To quote the old saw in the pharma industry, “If it isn’t recorded, it didn’t happen.”  It may well have, but if you don’t have the means to show that it did, then you can make no case for it. 

In the industry, when using a piece of equipment, it is important to first verify that the equipment is “within calibration,”  meaning that the equipment is within the period of time since its last calibration during which it can be presumed, barring some sort of unforeseen mechanical breakdown or other adverse circumstance, to be operating within the parameters set by the manufacturer, and therefore provides “correct” data.  There isn’t a known malfunction that is causing it to “skew” its output. 

Likewise, if we are to accept accusations from those attacking Hephzibah House, then it first has to be established that the accusers themselves are honest, that they are “calibrated” to give good data, so to speak.  In my article earlier this year about Hephzibah House, I demonstrated a number of reasons why the accusers against HH could NOT be taken seriously as credible, honest accusers.  There are simply too many holes in their stories, too many questions that they refuse to answer, too much of an unwillingness to have their claims be put to the test, too few evidences to support their assertions, too many reasons and motives that they would have to lie about HH and to try to destroy that ministry.  No fair-minded person can simply accept what they say at face value. 

All of these reasons – scriptural, America’s legal tradition, rigid standards imposed by my professional field – work together to demand evidence before accepting accusations.  Barring that evidence, I simply can’t in good faith accept them.  And until the accusers can see fit to bring forth evidence to back up their accusations, I see no reason to believe a word they say.