The Shadowy Sides of Clinical Trials

Coming up with a novel idea, setting up resources, hiring research specialists, launching R&D processes, developing and testing new drugs by different methods in a sophisticated laboratory and in animals doesn’t mean a breakthrough success. Well, if a drug shows positive results in an animal model, then the next main concern is testing the safety and efficacy of a drug in humans. If all goes well in clinical trials, then a new drug will emerge as ‘promising therapy’.

Carrying out clinical trials in an ethical manner with the consent of patients, besides getting nod from hospital management and health authority is agreeable.

But, what happens when sponsors of clinical trials try experimental drugs on pool of patients without a formal approval from government officials and consent of patients? Obviously, that’s breach in clinical research ethics.

Well, in poor countries, there’s every possibility of countless clinical trials reaching to conclusion without any proper consent from health authorities. So, poor nations, where there’s huge patient population, become tempting grounds for investigational drugs.

In one case, a registered medical practitioner, who has made fortune from his little clinic, dispensed a trial medication, at no cost, to a healthy patient. In few months, after taking the tablets, the patient suffered horrible side-effects that turned her obese. When the doctor was informed about this, he simply advised the patient to discontinue the medicine. Ah, but by placing the patient at risk of harm, the doctor succeeded in trying the medicine.

In reality, the gloomy situation is when shadowy clinical trial studies are conducted where there’s no patient consent and only a handful of doctors run the show in alliance with a hospital committee. It’s a complete violation! May be there could be an assumption that the new drug will not harm the patients.

But, who’ll be held responsible when injected or orally-taken drugs deteriorate patients’ health to death? Will someone expose ethical lapses in any funded clinical trial studies and bring severe side-effects into limelight or simply experimental drug results get suppressed without any investigation? At the end, what concerns is how a clinical trials study is designed and the type of data it generates i.e. positive, negative and minor ambiguous results.

Oftentimes, it’s a human greediness to make quick money through improper means, and such wrong intention can lead to perverse methods and unethical practices in conducting clinical trial studies. When a doctor doesn’t inform a patient and does a trial on him, then such a doctor can be labeled as a criminal. After this discrepancy, there remains no trust between a doctor and a patient.

In developed, rich countries, it’s hard to recruit right patients onto clinical trial studies. But, in developing countries where there’s abject poverty and scanty healthcare facilities, then it becomes easier for Big Pharma to experiment their investigational medicines on helpless patients.

Now, the big question is that: Are these patients informed about the experimental drugs in clinical trials or exploited without their agreement and awareness and are there any appropriate measures in place to safeguard these patients from any health risks?

What matters is patient safety, and not just corporate profits!

Image source: glasbergen.com – 2008 by Randy Glasbergen