January 18, 2013
With profits reaching into the billions, the United States pharmaceutical industry is one that continues to try to grow and expand. Pharmaceutical companies rely on doctors, the medical community, the FDA, and CDC to promote the safety of their drugs as well as encourage the use of their products. How do they do this? The answer is through drug trials.
These drug manufacturers must prove that their solutions are both safe and effective before they can hit the marketplace and reap big profits. To do this they must have human drug trials. But, in the United States, it is very difficult to find parents willing to subject their children to these trials. Because of this, many companies have moved an incredibly high percentage of their drug testing trials overseas. They aren’t just moving them overseas though. They are moving them to impoverished countries where informed consent is subjective and regulations are loose.
As recently as 1990, according to the inspector general of the Department of Health and Human Services, a mere 271 trials were being conducted in foreign countries of drugs intended for American use. By 2008, the number had risen to 6,485—an increase of more than 2,000 percent. A database being compiled by the National Institutes of Health has identified 58,788 such trials in 173 countries outside the United States since 2000.
These statistics were from 2008. The story gets much more grim as the years continue. We now have many drug companies solely testing overseas with no American trials being performed. Here are some of the major issues with this procedure of overseas testing:
Human Rights Ignored
When testing is done overseas, companies are released from the ethical and legal constraints of the United States. Though these products are going to be brought to the United States, they are not required to follow all the regulations. One example of how this practice can cause major ethical concerns is by forms of consent. In the summer of 2011, for instance, pharmaceutical giant Pfizer began making payments to families of Nigerian children who died of meningitis following a controversial drug trial marred by allegations of lack of consent, inadequate documentation and medical malpractice. Consent is easier to obtain in impoverished countries.
British drug manufacturer GlaxoSmithKline has recently been fined $230,000 by a court after 14 babies died during a vaccine drug trial. The company has been criticised for its handling of the tests and choice to locate the trial in a largely impoverished community, with many parents alleging that they were not informed of their children’s participation in a drug trial until after the vaccine had been administered.
These are just a few of the many examples of what can happen when loosely regulated drug trials on children take place in foreign countries. Ultimately, regulations in many foreign countries are less stringent, if there are any regulations at all. The risk of litigation is negligible, in some places nonexistent. This means drug companies have free rein and can test as they please. As an added bonus they don’t have to release test results performed abroad if they choose not to. This will be covered in a moment.
Are Findings Abroad Relevant to the United States?
Some health professionals also question if tests performed outside the United States are even relevant to treatment here. People in the areas of testing sometimes have little to no health history or past. It is easy for companies to find patients who have never had a drug in their lives. Therefore, reactions to the drug are less likely. Diets are different, medical interventions are different, and overall healthcare is different. This could cause patients to metabolize drugs differently and react differently to the drugs as a whole. This could deem those trials irrelevant to the American population.
Picking and Choosing
When drug trials are performed overseas the company has no obligation to release that data when applying for the drug to be released. They can pick and choose which trials to include in their application for the drug to come to market. Celebrex is a prime example of a drug tested overseas where clinical trials were narrowed down to only include the trials with best outcomes. In reading the Vanity Fair article you learn that:
The National Institutes of Health maintains a record of most—but by no means all—drug trials inside and outside the United States. The database counts 290 studies involving Celebrex. Companies are not required to report—and do not report—all studies conducted overseas. According to the database, of the 290 trials for Celebrex, 183 took place in the United States, meaning, one would assume, that 107 took place in other countries. But an informal, country-by-country accounting by VANITY FAIRturned up no fewer than 207 Celebrex trials in at least 36 other countries.
So why were all trials not included in the count to the National Institutes of Health? Could it be that studies showed patients taking the drug were more likely to suffer heart attacks and strokes than those who took older and cheaper painkillers? After consumption of this drug in the US, it turns out that this was in fact the case and sales of Celebrex dropped significantly.
Drug testing is a must to ensure safety of products before they reach market, but are we allowing the unethical treatment of children abroad to potentially benefit our own? What are your thoughts? Should there be heavier regulation in the pharmaceutical industry in testing and procedures for drugs to make it to the marketplace?