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by Dr. Mercola | mercola
Clinical research on humans is regarded as an essential component of drug research and development.
It is only after successfully being tested on people that drugs are supposed to be brought to market, but how can it be ethical to use people as guinea pigs in drug trials without fully informing them of what consequences they may face?
Typically such trials are only undertaken after there is evidence from animal experiments that the drugs are “safe and effective” …but this is far from a foolproof method by which to gauge safety.
Unfortunately, many die or are seriously injured after taking part in drug trials, and, worse still, only a fraction are ever compensated.
Thousands of People in India Died During Drug Trials
India is a popular place for drug clinical trials; the volunteer pool is huge and, for drug companies, the cost is low. In many cases, drug companies persuade the poor, illiterate, uneducated or tribal members to be their “willing” participants. But what’s the price for the trial participants who enter the testing?
Medical rights activist Anand Rai filed a Right to Information query to get data about drug-trial-related deaths and adverse events from the Drug Controller-General of India. It was revealed that more than 2,000 people in India died as a result of serious adverse events (SAEs) caused during drug trials from 2008-2011.
Only 22 cases, about 1 percent, received any compensation – which was a paltry average of about $4,800 per family. Drug companies often blame deaths that occur during trials on a person’s pre-existing medical condition. But experts say flimsy regulations that allow clinical trials to be conducted virtually anywhere “medical supervision” is present is to blame (and drug companies often pay doctors hefty sums to conduct such trials).
As The Hindu reported:1
“The reason for such a small number of cases receiving compensation is simple: Pharma companies conducting clinical trials pay compensation only in cases where it is established that the death was caused as a result of the trials and not merely during the trial.
‘But it is the companies themselves that decide whether a death was caused due to the trials or not. So there is a conflict of interest there as the companies want to pay compensation in the lowest possible number of cases,’ says Dr. Rai, who founded the Clinical Trial Victim Association of Madhya Pradesh.
‘We believe all cases of SAE-related deaths should receive compensation. We have filed a petition in the Supreme Court on the matter,’ says Dr. Rai.”
“Desperately Poor Recruits” Enroll Regardless of Potential Risks
What might drive someone to voluntarily enroll in a trial for a drug of questionable safety? Poverty, of course. India’s Drugs and Cosmetics Acts states that money cannot be used to be lured people into the trials, although a small compensation is allowed.
However, according to a Dateline NBC report, participants can actually earn up to $400 per study;2 in an area where the average worker earns 50 cents a day, and many go unemployed, this is a strong incentive. Not surprisingly, many of these volunteers will enroll in multiple studies at a time or enroll in another study before the “washout” period, designed to allow their body to become clean of the trial drug, has passed. This not only raises their health risks, it compromises study results.
And while drug companies do have some safeguards in place to prevent such occurrences, like using a thumbprint reader to enroll volunteers, one Indian insider told NBC that “if the companies need the subjects desperately, they will ignore these things.”
Further, there is little involvement from the Indian government to look into trial-related deaths or injuries, or reports of violations, such as not receiving proper consent from participants or unauthorized trials on children and mentally disabled patients. And although many of these trials are conducted by Western drug companies like Pfizer and AstraZeneca, which are seeking drug approval from the U.S. Food and Drug Administration (FDA), the FDA does not have jurisdiction to access confidential records under international law.
Gardasil Study Halted in India After 6 Children Died
In 2010, the government of India called a halt to trials of the Human Papilloma Virus (HPV) vaccine Gardasil. This came about because of a civil society-led investigation, which highlighted serious ethical violations for clinical research and informed consent rights of study participants or their legal guardians – and followed reports that six of the young participants had died, and more than 120 girls suffered severe adverse reactions, including:
- Stomach disorders
- Early menarche
Unfortunately, reports suggested the deaths occurred because the girls either committed suicide (by poisoning) or drowned – despite reports by parents to the contrary.3 This is, sadly, but one example of deaths occurring during drug trials.
Earlier this year, the Argentinean Federation of Health Professionals accused GlaxoSmithKline of misleading participants and pressuring impoverished, disadvantaged families into enrolling their children in clinical trials of the experimental Synflorix pediatric pneumonia vaccine.
Fourteen of the children participating in the experimental vaccine trial died.
The Nuremberg Code provides ethical guidelines for medical researchers to protect human test subjects in scientific experiments from injury, disability or death. The first principle of the Nuremberg Code – that doctors must obtain voluntary informed consent from the person about to be experimented on – appears to be frequently ignored, especially when it comes to clinical trials of experimental vaccines.
For example, according to Nigerian authorities, Pfizer illegally tested an unapproved drug on children with brain infections at a field hospital in 1996. Eleven of the children died and dozens were disabled before the illegal activity was exposed.
Again and again we see how major drug companies scheme to enlist people, who do not have full information about experimental vaccine or drug risks and are effectively turned into human guinea pigs in scientific experiments. In fact, this almost seems to be more the rule rather than the exception.
Outrageously, a paper published by the American Medical Association’s Virtual Mentor is concerned that current enrollment in U.S. vaccine trials is extremely low. 4 As a solution, the authors propose a federal law that would force all Americans to “opt-out” if they do not want to participate in vaccine trials or let their children be used in vaccine trials…
Drug Trials Plagued by “Ethical Dilemmas” Even in the U.S.
India in particular has seen an upsurge of clinical pharmaceutical studies, and the questionable practices employed are becoming increasingly apparent. But there are problems in other developing and developed countries as well, including in the United States.
In an essay just published in The New England Journal of Medicine, the authors point out “critical weaknesses” in the national system of ensuring drug safety that not only let dangerous drugs like Avandia, Vioxx and Celebrex hit the market, but also enroll volunteers into post-market clinical trials without disclosing the true extent of the risks.
When signing up for a post-market drug trial, patients must understand that they may be exposed to an exceptionally dangerous drug – one that is typically being tested because of suspicions that it may be causing severe side effects. But volunteers are not typically told why exactly the trial is being conducted.
The debate heated up in 2010, when the FDA restricted the use of the diabetes drug Avandia after post-market trials showed patients using it had an increased risk of heart attack and stroke – a risk the drug maker, GlaxoSmithKline, knew about but did not tell patients.
You’re Your Own Best Advocate
The take-home message here is that even if a drug or treatment is “backed by science” or in the midst of clinical trials, this in no way guarantees it is safe or effective. Likewise, if an alternative treatment has not been published in a medical journal, it does not mean it is unsafe or ineffective.
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