The FDA Should Ban Foreign Clinical Studies of Drugs

Among several relatively unknown activities that lead to exploitation of the innocents, foreign clinical studies or drug trials is one such act carried out by giant multinational pharmaceutical firms. The big name pharmaceutical firms in the US and UK depend on conducting clinical trials in nations such as India and other poor countries to reduce their overall drug development costs by about 40-60%. By 2010, it is assumed that the total spend on outsourcing clinical trials to India is to exceed $2Billion. Having seen how doctors and hospitals behave in a country like India, it is pretty certain how the ignorant (it doesn’t matter whether you are poor or rich) can be taken undue advantage of to satisfy the needs of these companies.
Doctors and Hospitals in India have less at stake when it comes to safe recommendation and regulation of medication for patients. In a World that wakes up and sleeps to the music of money, the only stick that holds greed at bay is confirmation to strict legal regulations. Without a strong legal base in a country, the law remains powerless when it comes to monitoring the greedy acts of companies. When a doctor prescribes a “special” medicine to an ignorant patient on the behest of a pharmaceutical firm working to test those drugs, there is nothing within the legal rights of the patient to stop such acts. India has a lot of laws that prescribe the right conduct of such trials and these companies make sure that these legal edicts are safely followed on paper. Unfortunately, in countries where issues do not even reach the doors of the law for justice to be served, the end result is the lack of any law in the first place. India and several other materialistically poor nations suffer from this incurable disease. I have personally observed how daunting an experience it is talking with doctors and hospital/clinic staff who literally have a free ride in not only recommending any number of medications they like without fear of being legally sued, but also have the audacity to scold or threaten patients if things are not to their liking. Several of these doctors are constantly approached by medical representatives, who act as a sales front for the pharmaceutical firms. Sometimes, in the guise of an informed consent, they literally dump new medications or slow-moving medications to unwary patients. One can only imagine how it would look like for the largely poorer or ignorant sections that constitutes about 70% of the Indian population.
In all this melee hides a silent and often ignorant sleeping giant – the FDA. The FDA authorizes foreign clinical studies as long as it abides by the regulations set by the host country (where the trial is conducted mostly in secrecy) or to other ethical principles under the Declaration of Helsinki (which I believe is no longer relevant), whichever protects human rights better. This unfortunately is a mere fallacy that has no practical meaning whatsoever. All the profit making pharmaceutical firms in the World look forward to the FDA as the gate keeper who opens them to the mecca of blockbuster drug sales – the USA. The US is one of the largest consumers of prescription drugs and one of the most profitable markets for any drug company. Fortunately, this country has the FDA to hopefully regulate the kind of drugs brought out into the market and its long term use and existence. Also, a network of well organized lawyers later ensure that these firms are selling what they promise they cure or else slap them with multi-million dollar law suits that usually work in favor of the “cheated” patient. Unfortunately, the FDA is not thinking in clear terms when it comes to how these companies work to meet the requirements of their strong codes of conduct.
The FDA does not have the resources nor a nationalistic purpose to clearly monitor the often obscure methods employed by these large drug companies in conducting their trials in remote areas of Asia or Africa. The FDA has to answer the US government and its citizens and that is all it is driven by as a daily mantra for ensuring that quality foods and drugs enter the US. In such a state of affairs, the FDA should be morally more inclined to not accept any foreign clinical trials unless it has it own people closely monitoring that process. In fact, to take it a step further, it is completely wrong on the part of the FDA to allow such foreign tests on human guinea pigs when it as an agency does not have the power to dictate how other countries should regulate the action of drug companies in their soil. The guiding principle of “informed consent” as a signature on a blank check for legally authorizing companies to conduct tests on people is an entirely weak argument when it is easily realized that poor people hardly have the power or the knowledge to understand their rights in the first place. It is very unfortunate that this greedy act that largely benefits profit seeking multinational drug companies is allowed to continue in the name of giving healthy, “well tested” drugs to the “developed” nations of the world.
After all, these well tested and safe drugs are either heavily expensive or never reach the poor countries that largely test it. It is usually the cheap ripoffs or generics that are either affordable or available to large sections of the population in countries such as India. To make matters worse, in the name of protecting so called patents, the large drug companies have used the WTO to force countries like India from reverse-engineering these drugs to create cheaper alternatives. So now, not only do people in India test themselves with these drugs but never get to use them if they really need it.