In the past decade, pharmaceutical companies, along with other manufacturing businesses, have gone global. With increased speed and reduced cost of development, pharmaceutical production has improved in efficiency. Skeptics, however, raise ethical questions concerning human rights in developing third-world countries.
While poor countries cannot afford up to $2,200 for existing therapy, rich countries should not be obligated to provide these expensive treatments in return for doing research.
The use of placebos - or dummy medications - should be permitted, as long as it is administered with informed consent. Even with dummy medication, subjects only can benefit from increased medical care in countries where health care virtually is nonexistent. At the same time, the medication can be marketed more quickly, and its benefits spread more widely.
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Placebos are not harmful. Consenting subjects place themselves at no risk, even if they are misinformed. People around the world suffer from potentially deadly diseases, whether it is RDS or AIDS. Yet doctors cannot travel the globe treating everyone they encounter. Citizens of third-world countries readily would sign up for placebo experiments to improve or maintain their current state, and also perform a service for the scientific community.
Industries other than medicine also take advantage of less-developed countries. For many years, General Motors, PepsiCo. and other companies have used low-cost foreign factories to develop their products. Although the pay scale may be low by American standards, the factories still offer thousands of jobs. Though factory workers cannot afford to drive a Saab or enjoy a soda, many Americans would be reluctant to give up their Mountain Dew.
Peter Lurie of the consumer advocacy group Public Citizen argues that Discovery Labs should not have lower standards of care for the Latin American study than they would for a U.S. study. While standard care in American hospitals includes administering effective drugs, a placebo study would not make sense in the United States. Informed participants most likely would not consent to receive fake treatment if they actually could afford medications that may save their lives. After all, they have nothing to lose.
Third-world countries sometimes are forced to have lower standards. In underdeveloped countries, many sick people simply cannot afford life-saving medication. Thus affordable treatments, albeit less effective, should not be denied to them. Discovery Labs President Robert Capetola says his company will donate ventilators and antibiotics for infants in the study. Even if they may not receive a cure, the subjects often receive better treatment than would have otherwise been available. Few people would claim it is unethical to feed a hungry man a single meal because it is too expensive to feed him for a lifetime.
While Lurie denounces the study as "unethical and exploitive," Capetola claims that taking out the placebo portion of the study would hinder drug application by at least a year. That could mean the loss of lives - even though no one would be worse off from placebo treatment. Capetola steadfastly added, "It's unethical not to do it."
Development of new drugs can last over a decade, with most of this time being devoted to clinical trials. Experiments in the United States involve a great deal of governmental oversight and documentation. Clinical trials abroad, however, do not need approval from the Food and Drug Administration until they become part of a new drug application to be released in the United States.
While the experiments are under the jurisdiction of host countries, regulations often are less rigorous than inside the United States. Developing countries promise cheaper and faster results with less red tape.
In some countries, large numbers of sick people sign up more readily because they lack basic health care. Problems only arise when participants do not understand the potential dangers in studies with novel drugs.
By FDA regulations, written consent is necessary for clinical studies even outside the United States. The FDA struggles to police the informed consent regulations for children, non-English speakers, illiterate and demented persons.
Oral explanations are often necessary with a third-party witness. Consent in third-world countries must be policed in a similar manner.
The authority of U.S. regulators ends at the border. But, the FDA acts as the final judge over medications released in the American marketplace, effectively imposing consent requirements for all drugs.
All test results may be questioned as evidence if a drug is safe and effective. Data integrity and informed consent are necessary both within and outside of the United States.
Placebos are used for control groups around the world, one of the foundations of the scientific method. Without a control group, the variable being tested cannot be compared to anything.
University laboratories often use salt solutions or sugar pills as placebos to test the effectiveness of drugs. Those concerned with ethics also must take this problem with a grain of salt to seek a cure for informed consent and verifiable data, domestic and foreign.
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