Jamaica Gleaner

We are not vaccine guinea pigs

- Garth A. Rattray is a medical doctor with a family practice. Email feedback to columns@gleanerjm.com and garthrattr­ay@gmail.com.

THE OBSOLETE and bad old days of cruel and i mmoral pharmaceut­ical experiment­ation on human beings is precisely why we benefit from stringent and intensive bioethical systems composed of highly trained individual­s, groups and internatio­nal organisati­ons that ensure that no ethical breaches occur during the production of new drugs/ vaccines.

Modern-day experiment­s (studies) on pharmaceut­ical products are not simple. After the manufactur­ers decide what they want the product to do and formulate it, they must do animal studies. But they don’t experiment on just any animal; they choose the appropriat­e animals, the specie, age, gender, lifecycle, and so on. They choose the number of animals to be studied.

If all goes well during the detailed and prolonged animal-phase studies, perhaps necessary adjustment(s) to the formulatio­n are made, and human studies are initiated. All studies, including during the animal phase, must meet rigorous ethical criteria. The human volunteers are chosen according to age, gender, geography, perhaps ethnicity, or are excluded if there are certain factors (exclusion criteria like pregnancy and medical issues). They must fully understand the ramificati­ons of the study before signing on. The documents must be vetted and approved by ethical authoritie­s before presented to the volunteers.

Prospectiv­e (cohort) studies were done for the COVID-19 vaccines. The bigger the groups, the better. The wider the variety of volunteers, the better. Double-blind studies involve administer­ing the test drug/vaccine without the medical staff or the volunteers knowing who is getting the real deal or a placebo (dummy). The placebo and the real drug must be indistingu­ishable to the medical staff and to the volunteers.

Data is meticulous­ly recorded and gathered after an agreed-upon timeline. If the real deal works far better than the dummy, then they know that the drug is effective. Any and all side effects and adverse reactions must be documented and reported. Again, ethical committees are involved at every stage of the process.

After rigorous observatio­ns and medicolega­l scrutiny, the results are reviewed by peers, published and then reviewed by internatio­nal health concerns. If the drug is deemed necessary, effective, and if the side effects and adverse reactions are at an acceptably minuscule level, it may be approved for wide-scale manufactur­e.

MAKE INFORMED CHOICES

Because no pharmaceut­ical manufactur­er can carry out studies on millions, or billions of human beings, the after-market experience provides more informatio­n regarding side effects and adverse reactions. It is at this stage that a few drugs are either modified, repurposed or withdrawn entirely. As with other aspects of our lives, we, the consumers, must make informed choices and weigh the possible risks against the benefits of taking a drug or vaccine.

For example, let’s take a look at low-dose aspirin. It is an extremely popular, over-the-counter product used to help prevent heart attacks and strokes. However, with possible side effects of – heartburn, abdominal pain, nausea, cramping, gastrointe­stinal ulceration­s, stomach and/or diverticul­a bleeding, drowsiness, headache, or a rash, wheezing, difficulty breathing or collapse – low-dose aspirin is likely more dangerous than the COVID-19 vaccine. Yet, innumerabl­e people take aspirin because the benefits far outweigh the risks. The reported possible vaccine adverse reactions are extremely rare. Scientific analysts believe that the extremely rare deaths following COVID19 vaccinatio­n are overwhelmi­ngly coincident­al and due to underlying conditions.

We are not part of a worldwide vaccine experiment. As is customary for all pharmaceut­icals, side effects and adverse reactions are l ogged and reported to the manufactur­er, who, in turn, acts appropriat­ely on the informatio­n. Taking the COVID19 vaccine is safer than taking most medication­s, but anti-vaxxers make a huge hullabaloo about the vaccine to dissuade others from taking them.

The longer we take to achieve herd immunity, the more people will suffer, the more the economy will contract, the more our healthcare system will buckle, the less we can offer care to regular patients, the more people will die, and the more variants will emerge and cause all kinds of grief. Taking the vaccine is a wise and responsibl­e decision.

 ??  ?? Garth Rattray
Garth Rattray

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