“It’s not good for our economy or our national security.” – FDA Commissioner Robert Califf in a statement about offshore drug trials
Beyond the damage that drug companies have caused by failing to disclose dangers or pushing for drugs that sustain customers rather than curing diseases, there is a dirty underbelly to Big Pharma that many people do not realize exists. This secret world is dangerous and destroys lives, and it is happening while much of the world turns a blind eye.
People living in developing countries in South and Central America and in Africa have long been subject of dangerous drug trials, called offshore testing or offshore trials, for medications and products that have never been tested for use in humans. People in remote villages or other poor areas are treated like laboratory rats, and the results are frequently devastating
For example, offshore trials by drug czar Pfizer killed 11 children and left dozens disabled in Nigeria when newly developed drug Trovan was brought in for experimental purposes in 1996.
During the trial, which occurred during a meningitis outbreak, patients and families were not aware that Doctors Without Borders was providing free, proven-effective antibiotics at a medical camp nearby. When Pfizer left Nigeria, it failed to offer long-term follow-up to its human trial participants. Trovan was later discovered to cause a high risk of acute liver failure. This episode illustrates the perils of a lack of effective governmental oversight.
Secrecy and Offshore Drug Trials
This is not an isolated incident. Every year, children and other “subjects”of these trials die or are seriously injured from administration of experimental vaccines, medications, and treatments. Until recently, they all died silently. Pharmaceutical companies were not held accountable. Today, that is slowly changing, but it still happens far too often.
According to the Mayo Clinic, “In a study of 33 new products tested in Latin America and approved by the FDA in 2011 and 2012, 21 (80%) of the 26 products were shown to offer no therapeutic advantage over existing treatments and to have considerable adverse effects. Moreover, many of these drugs were never marketed in the host country or were marketed at prices not affordable to local residents.”
Even when Americans are subjects of these trials, they are sometimes conducted in countries where drug companies can operate freely without regulation. Flying U.S. patients to under regulated countries for testing is also a concern, as documented by National Institutes of Health in 2018.
The pharmaceutical industry is continuing to grow exponentially. With this growth, the importance of ensuring drugs are safe and effective before they reach the market is vital. Propaganda put out by Big Pharma would have you believe that these companies are as compassionate as they are scientific. Some of the patients who survive these trials would argue that this is not true.
The hard truth is that, for pharmaceutical companies, the bottom line is of the utmost importance. They use developing countries for cheap labor to produce drugs, and also because a lack of regulations allows them to conduct deadly human experiments.
These “secrets” are not so obscure anymore. Cell phones and internet coverage has reached many of the farthest corners of the planet, and with them has come the ability for people to bear witness and speak out.
Still, people in poor and remote areas are not always aware that they have been wronged. They don’t always realize that the shots or medications brought by Europeans or Americans caused injuries or deaths, and even when they do, they do not always realize that they have recourse. And, of course, sometimes they don’t.
And, of course, the sad truth is that many Americans would rather look the other way knowing that someone living in a faraway village was harmed and not one of their loved ones. But as the world becomes more accessible, the tide is turning. Many people now recognize that we are, indeed, a global community, and that there is a better way to address these problems.
FDA Raising Awareness, Urging Change for Offshore Trials
The Food and Drug Administration (FDA), along with watch groups and non-governmental organizations, has growing concerns over drug testing on vulnerable communities, particularly because of its legal and ethical implications.
Rick Pazdur, the FDA’s top oncologist, is vocally against these offshore trials. He has publicly acknowledged that their purpose is to save money, and not as drug companies claim, which is to extend a compassionate hand to poor populations.
As well as the legal and ethical problems, FDA commissioner Robert Califf recognized another issue: “It’s not good for our economy or our national security.” When offshore trials go wrong, they can create diplomatic concerns and threaten relations between people of both countries.
“I’m 100% in favor of globalization,” added Califf. “But [I am] 100% opposed to offshoring as a financial arbitrage.”
Offshore Testing Health Risks for Americans
Aside from the risks to populations in developing countries, the risks facing Americans, who will inevitably be using the drugs, are serious. Offshore trial results do not represent most American genetic populations, to begin. These trials are being conducted on people with completely different lifestyles and genetics, different to those who will ultimately be buying the drugs, creating misleading conclusions on the safety and efficacy of the drugs.
Said Califf, “They’re using patients here, and we have to always make sure patients aren’t considered commodities.” Moving these experiments to well-regulated and more representative trial settings in the U.S. and Europe are the best solution, he added.
In addition, side effects have been known to be underreported or not reported at all in offshore trials. Without a regulatory body, drug companies regulate themselves, and it is in their best interest to form conclusions that support the sale of their drugs. This can mean lying about trial data.
Of course, when this happens, it is trusting American patients who suffer most.
Is Onshore Testing the Best Option?
There is always an element of NIMBY — or “not in my back yard” — when it comes to controversial topics like experimental drug testing. Drug companies often argue that they are testing new therapies on populations who are exposed to disease or illness but who have no alternative treatments available. Of course, as with the Pfizer meningitis drug testing, this is frequently not true.
Also, if that were so, there are countless people in the U.S. and Europe who are suffering without alternative treatments. There has been a strong precedent set for well-regulated onshore testing programs. Some drugmakers have indeed shifted to onshore testing in order to be more ethical and accurate in their procedures. But some pharmaceutical companies still use places where poor people live as their deadly playgrounds.
Why is Onshore Testing Important?
Onshore drug trials would allow the FDA to monitor the process and ensure patient safety is the main priority. When drugs are discovered to be dangerous or ineffective in offshore trials, pharmaceutical companies can dodge accountability. U.S. courts are capable of holding companies accountable for negative defects in their drugs when the trial is conducted onshore, meaning there is much more protection for patients.
If they were truly developing and testing these drugs out of kindness or a need to contribute to humanity, they would value all humanity and play by the rules wherever they are. Instead, they treat entire villages and communities like human laboratories.
In the 2011 Pfizer ruling, the $35 million they ultimately gave to the region of Kano in Nigeria, where meningitis drug testing took place, was. not a show of empathy to those affected there. It was a cheap price to pay to keep the adjective “compassionate” beside their name. Had they not been caught, they would have happily gotten away with murder. People in that region were, after all, a commodity to the drug company, and it was never about patient care.
Ames Dhai from the University of Witwatersrand in South Africa commented on the problem. “Less stringent ethical review, anticipated under-reporting of side effects, and the lower risk of litigation make carrying out research in the developing world less demanding.”
The FDA’s primary role is to ensure the safety and well-being of patients across the U.S., and their push for onshore drug trials does not necessarily mean that all trials should be conducted in the United States. The push is essentially one that forces the pharmaceutical industry to create a clear balance between cost and ethics.
If large pharmaceutical companies truly care about their customers and patients as much as they say they do, they will follow the FDA’s recommendation. Only then will people in developing countries be safe from dangerous experiments.
Maybe then they will start valuing patient health over profits.