A possible solution to the drug (substance) question, but first some
questions. What is the clearance time for rhino vaccine? What is an
abnormal amount of biotin? Is a topical anti-biotic impermissible under
"administration of abnormal substances"? How about one being fed or
injected? What about a topical antisceptic?
I raise these questions because the problem is not how a substance is
classified (which is largely a product of FDA law and not science). There
appears to be a good consensus on this list that any substance used to help
the horse in any way during a competitive event that has negative
consequences on the health of the horse should be banned and that a
substance that helps the horse's long term health should be allowed. The
problem, as the above questions point out, is that no classification system
does that successfully. Each substance must stand or fall on its own
merits. The other problem is that there is disagreement on what substances
meet this test.
What is needed is a list of approved substances. I know Dr. Frazier had
indicated historical reasons relating to other rules about what substances
should be allowed led to the current broad brush rule, particularly because
under those rules, bute an others became approved substances.
The following from Dane Lee Frazier:
"Therefore, we felt the only chance to have enforceable and meaningful
rules about drugs in endurance riding was to prohibit them instead of
trying to regulate them. Regulation means that you will allow drugs --
only you will fight about which ones and how much. Prohibition means
that you will not allow drugs and you will fight about what is a drug."
You will also argue about clearance times. Since it requires a month for a
loading dose of Flex-Free, I would assume clearance time would be at least
that long. You also throw the technical burden on those who are not
technically oriented. From the questions I first asked in this post, it
appears that some drugs are exempt (under some unstated common sense
doctrine?) from the rule.
The possible solution: An approved list of substances. No others could be
used. In keeping with a philosophy that errs on the side of banning
questionable substances, a substance could be added to the list only with
a two thirds affirmative vote and could be removed with a one third
affirmative vote. The arguments will still be there, but the list of
substances actually approved is going to be a conservative list.
Duncan Fletcher
dfletche@gte.net
----------
> From: Ramey Peticolas-Stroud <ramey@wvi.com>
> To: Dane Lee Frazier <dfrazier@mail.llion.org>
> Cc: Ridecamp@endurance.net
> Subject: Re: Drug Policy Info (Long)
> Date: Monday, December 16, 1996 2:23 PM
>
> Dane and those of you interested in our AERC drug rule thread:
>
> Please forgive me for taking so long to respond to Dane's last post on
> the procedural and substantive aspects of the AERC Drug Policy. I
> needed time to think and do some reading.
>
> In this post I will try to briefly summarize our discussion to date and
> explain why AERC really has TWO drug rules. Next, I'll try to explain
> how AERC apparently uses a very old common law doctrine in prosecuting
> drug cases. Finally, I'll close with a few observations.
>
> I. Summary of Posts To Date
>
> To begin, there are at least four groups involved with the AERC drug
> rule. Those who are responsible for developing and enforcing the
> policy; those who generally understand and agree with the rule as
> written; those who are somewhat confused as to the scope and application
> of the rule; and finally, those who produce products impacted by the
> rule. To date, manufacturers of drugs/nutraceuticals have not been a
> party to our discussion.
>
> We have learned that AERC Rule 13 requires endurance equines to compete
> entirely on their natural ability. The rule specifically prohibits from
> competition "equines who contain evidence of the administration of
> abnormal substances or of normal substances in abnormal amounts
> (exogenously administered compounds even if normally found
> endogenously)." If one reads this quoted portion of Rule 13 carefully,
> it becomes obvious that there are TWO ways to violate the rule.
>
> The first type of drug prosecution involves the phrase "administration
> of abnormal substances." This is the pharmaceutical (licensed drug)
> aspect of the rule. Dane has written that a: "drug is a substance that
> has a physiological effect THAT IS NOT A NUTRIENT. All nutrients are
> included in one of six classes: (1.) water; (2.) protein; (3.) vitamins;
> (4.) carbohydrate; (5.) fat; (6.) minerals." (Emphasis mine.) There is
> little disagreement the licensed drugs at issue are not normally found
> in the equine body.
>
> Although pharmaceutical cases are more clear cut, they still give rise
> to the problem of clearance times. In many posts, 72 hours has been
> mentioned. However, current laboratory methods can detect substance in
> parts-per-billion and, therefore, 72 hours may not be long enough to
> prevent a positive test. To this point, no writer has been able to
> explain how AERC differentiates between a positive (violation) and a
> positive (residual non-violation). This is interesting in that I am
> told by professors at our local vet school that many drugs, bute for
> example, may leave detectable amounts in the equine blood stream for
> months and even years after administration. The AERC BoD and the Vet
> Committee feel strongly that riders and members are responsible for
> solving the clearance time problem.
>
> The second violation concept in Rule 13 deals with so-called
> nutraceuticals. At the out-set of this part of the discussion let me
> make a correction to my post on the "intent to improve performance"
> (i.e. the mens rea discussion). I have studied both the AERC Rules on
> the AERC Homepage and the latest version in my library (1994). Unless
> revisions have been made since these two sources were published, THERE
> IS NO SUCH INTENT ELEMENT IN AERC RULE 13. I apologize for not
> immediately going to the source document instead of relying on E-net
> quotes.
>
> What Rule 13 does say about nutraceuticals is "AERC prohibits from
> competition equines who contain evidence of . . . normal substances in
> abnormal amounts (exogenously administered compounds even if normally
> found endogenously)." There is no published AERC definition of the
> terms "abnormal amounts" or "exogenously administered compounds." There
> is a partial list of substances/nutraceuticals banned during competition
> published by AERC. This list apparently does not indicate relevant
> clearance times. Again, riders/members have complete responsibility to
> determine (1) whether their exogenously administered compounds (the
> stuff we are feeding) are not normally occurring in their horse, and (2)
> will the substance result in a positive drug test. Advertising claims
> from manufacturers are not a defense.
>
> To conclude this portion of the post, I'll summarize the AERC position
> by again quoting Dane: "Therefore, it becomes the obligation of the
> owner/rider to take responsibility for the compounds given their horse.
> If they are unsure as to the effect of anything they may administer,
> then withdrawing the substance so that it has no effect on performance
> during competition is prudent."
>
> II. The Common Law Doctrine of Res Ipsa Loquitur
> (The Act Speaks For Itself).
>
> Dane mentioned that a positive drug test was accepted by the BoD as
> conclusive evidence of a Rule 13 violation: "the thing speaks for
> itself," he said. What he was referring to was a very, very old common
> law rule of evidence. Within the limits of my DIMR, I'll try to explain
> it.
> All Americans, either by birth or naturalization, are guaranteed
> certain fundamental rights. For purposes of this discussion, these
> rights are extended to citizens of other countries by either their
> membership in AERC or by participation in an AERC sanctioned event. One
> such fundamental right is that we are considered innocent until proven
> guilty. In other words, the state has the burden of proving the
> defendant committed the crime. In civil matters the person making the
> claim usually has the burden of proving their case. That is, once all
> elements of the plaintiff's legal theory (a prima facie case) has been
> presented by the plaintiff, the defendant has a right to rebut the
> evidence and/or explain why that evidence doesn't matter.
>
> There are exceptions to the rule. The Doctrine of Res Ipsa Loquitur is
> a common law concept that shifts the burden of proof in civil cases from
> the plaintiff (in this case, AERC) to the defendant (the owner/rider of
> the horse). The doctrine applies to events that only occur where there
> has been some negligent act. Stated differently, some courts conclude
> that the OCCURRENCE ITSELF is enough to prove negligence. For example,
> if you cut your mouth on a chunk of glass that was in a can of peas
> opened just before eating, the presence of the glass alone may be enough
> to shift the burden of proof to the cannery. In other words, but for
> some negligence, cans of peas do not contain glass.
>
> To invoke the Res Ipsa doctrine in Rule 13 cases, AERC must generally
> prove three things: (1) A positive drug test does not normally occur
> unless there was prohibited conduct; (2) Such conduct is within the
> scope of duty the member owes to AERC; and, (3) Neither AERC nor some
> third party contributed to or caused the positive test.
>
> I'll attempt to explain. In Step (1) AERC will use expert testimony to
> show that a blood and/or urine test came back positive. The actual
> administration of drugs may be shown by inference. That is, direct
> witnesses are not needed, only that the rider or owner entered the
> drug-positive horse in the AERC sanctioned event.
> Step (2) is satisfied when a members joins AERC or a rider enters an
> AERC sanctioned event; those acts alone represent agreement to comply
> with all AERC rules. The promise not break AERC rules then becomes an
> absolute duty owed to AERC.
> To satisfy Step (3) AERC must show that neither they nor some third
> party contributed to or caused the positive test. This is where the
> sampling procedures, the chain-of evidence and the laboratory process
> come into play. AERC must unconditionally prove that all uniform
> procedures were followed to the letter.
>
> If AERC can meet this three part test, then under the res ipsa concept
> the responsibility of going forward with the evidence shifts to the
> owner/rider. Possible defense strategies can be the subject of a future
> post if there's interest.
>
> III. Conclusion
>
> It is obvious now that AERC has adopted an extremely simple way to deal
> with equine drugs and nutraceuticals. The vet and rules committees,
> with BoD approval, have avoided a lot of work by shifting total
> responsibility for compliance to owners and riders. Under the current
> rule, members must either become or hire biochemists to determine what's
> in every substance, drug, remedy, herb, nutraceutical, foodstuff or
> product given to their horses. Further, members are entirely
> responsible for determining minimum clearance times.
>
> Is shifting the scientific burden to members rational? Is it fair? Is
> there a reasonable alternative? What responsibility do manufacturers
> have, if any? These are political questions for future discussion.
>
> Our family is heading to the Death Valley Multiday so I'll address any
> questions when we return. Good cheer to all and a happy new ride year.
>
> Ramey.