Tanielle | Beyond Briana – introduce pharma registry

Briana Williams is one to watch. The amazingly talented sprinter holds the world age-15 best (11.13s) for the 100m and is our national junior record holder at 10.94s.

Williams recently tested positive for a prohibited substance, hydrochlorothiazide (HCTZ), a preferred diuretic commonly prescribed to treat high blood pressure and edema. HCTZ is similar to a common diuretic, furosemide (lasix). Diuretics are considered masking agents and are banned substances under the WADA code Section S5 (January 2019).

In recent years a number of Jamaica’s track and field athletes have tested positive for diuretics, namely furosemide (lasix). According to WADA data from 2017, diuretics accounted for 15 per cent (614 cases) of all adverse analytical findings (AAF), with furosemide being detected in the majority of cases, followed by HCTZ. Diuretics are detected at 250ng/ml as evidence of misuse in sports. This is the minimum required performance level (MRPL) prescribed by WADA.

Diuretics are a class of drugs that increase urine output or the excretion of water thereby increasing the loss of water weight, and the exit of substances or metabolites from the body. Diuretics also serve to alter urine pH. Diuretics are prohibited in all sports and are considered masking agents, in light of their potent ability to dilute and eliminate the metabolites of substances quickly from the body; and allow for a rapid change in weight. The illicit use of diuretics is problematic for doping-control officials because of its quick exit from the body, usually within 24-48 hours.

HCTZ represents a thiazide diuretic containing sulphur and nitrogen that works by significantly increasing urine output, by hindering the reabsorption of sodium and chlorine by the kidneys. Clinical trials indicate that the half-life of HCTZ is approximately five hours, with blood-concentration levels peaking two hours after ingestion of a single dose. However, its pharmacodynamic response is said to be prolonged beyond its half-life. HCTZ is excreted from the body through the urine partially metabolised.

Briana Williams’s case as presented so far suggests that the presence of HCTZ metabolites in her urine is as a result of ingesting a cold and flu (multisymptom) over-the-counter medication, which was declared on her doping-control form. Subsequently, the OTC was tested and also found to contain significant quantities of HTCZ. The OTC medication in question does not list HCTZ as one of the ingredients.

This then brings us to the problem of contaminated drugs that do not list all active or inert ingredients.

Contract Manufacturing

Many pharmaceuticals are manufactured in contracted facilities (CMO). This trend is set to increase in coming years with an estimated industry worth of US$205 billion by 2021. While CMOs represent greater efficiency and possibly lower cost for pharmaceuticals, there are a number of concerns surrounding this industry, mainly quality issues such as contaminants and adherence to product standards. CMOs will argue that these issues emanate from just a handful of companies and, as such, whitewashing the industry is not acceptable.

Manufacturers of drugs may include unlisted ingredients in order to save on the cost of a particular active ingredient, by inserting an additive drug that can enhance the effects of the drugs listed. Manufacturers are then able to ensure consumers will see the drugs as having the desired effect.

Quality issues will surface where manufacturers do not ensure proper cleaning is carried out in-between batches of different classes of drugs that may use the same manufacturing line within the factory. Food manufacturers avoid these challenges by stating clearly on their labels that their products are manufactured in facilities that also process other substances. A check of pharmaceutical labels does not indicate this information.

These concerns associated with the manufacture of drugs then produces challenges for all athletes who may take OTC or other prescribed medication.

National Responsibility

So how do we protect ourselves and our nation’s athletes from contaminated OTC drugs, prescribed drugs and supplements? The IAAF, through the Athletics Integrity Unit (AIU), has a website, informed-sport.com, which allows one to search by brand, and batch ID for products that have been tested for prohibited substances from the WADA list. The motto of the website is ‘We test, you trust’. A scan of the website, however, failed to include the OTC mentioned in this case. As such, the dilemma remains then for local athletes who may purchase items from their neighbourhood pharmacy.

Many pharmaceuticals are produced for specific markets, and this website, though very useful, will not cover all the pharmaceuticals coming into the island for sale.

As such, it is very important that as a sporting nation, a designation we take pride in (shout out to the Jamaican ice hockey team), we take a proactive approach to protecting our nation’s sportsmen and women.

A local registry with all the pharmaceuticals sold in the island must be established and available for athletes to view. This portal should include the batch numbers with certificates of conformity from the manufacturers that these substances are free of contaminating substances.

Of course, we should not leave anything to chance. Local expertise and the technology are available for us to undertake this comprehensive listing. Establishing integrity and trust within the athletic community in relation to OTCs, prescriptions and supplements should be our focus. This portal should be then incorporated into the framework of JADCO’s anti-doping efforts.

A situation like this should not be repeated. We must protect our athletes. The psychological toll of an adverse analytical finding is significant, especially on our promising future stars.

Let us take action now.

 

Tanielle is a published research scientist, currently pursuing her PhD in biochemistry. She is also a public speaker and Level 1 IAAF certified technical official. Email feedback to columns@gleanerjm.com and tanielleb@gmail.com.