Does Outsourcing Threaten Your Chances at a Cure?
Reportedly it costs approximately $800 million to bring a single drug to market and this cost is steadily rising for pharmaceutical companies. The bulk of the new drug development expenses are associated with clinical trials. In an effort to to lower the costs, companies are increasingly testing their drugs in developing countries, a practice known as outsourcing.
Clinical trials in the US cost approximately $150 million dollars, 60% more than they cost to conduct in India. Pharmaceutical companies can also conduct their clinical trials in China, South America, and Eastern Europe for considerably less.
Cost isn’t the only factor. Pharmaceutical companies are working on a tight timeline to conduct their clinical trials, get FDA drug approval, and market their drugs to the public so they can start recuperating the cost of drug development. These companies need to enroll hundreds or thousands of volunteers for the clinical trials.
In a 2008 bulletin, the FDA recognizes that finding and enrolling patients in a trial in US is the most time consuming part of the study. Some studies never enroll the number of patients they need to conduct the trial. Outsourcing clinical trials to developing countries can fill out the required volunteer slots and cut recruitment time in half.
In the US, not only is it difficult to get the word out to physicians about an active trial, but its hard to make sure that information is passed on to the patients. Moreover, many Americans are hesitant to join trials despite the possibility of improved results over standard therapy.
According to the Los Angeles Times, only 3% to 5% of adult cancer patients enroll in clinical trials. Volunteers in developing countries are more willing to participate because they get medical attention they otherwise wouldn’t get or couldn’t afford in their country and compensation in some cases can be equivalent to a year’s salary.
There are several major reasons Americans should be concerned about the practice of outsourcing clinical trials.
(1) While there are risks associated with new, untested medications or procedures, a trial participant gets access to medications that might otherwise not use (because of insurance or other limitations) and quality medical care, more thorough visits, and tests. When you’re sick this can make the difference between life and death.
In the case of breast cancer survivor, Carol Ott Schacht, as a result of extra testing provided during her clinical trial, physicians found out she had an aggressive cancer that required a different therapeutic regimen then what she would have been regularly prescribed at her regular oncologist’s office. If trials are outsourced, many patients like Carol Ott Schact wouldn’t have the opportunity to receive experimental care that could save their lives.
(2) Outsourcing clinical trials means that new drugs aren’t necessarily being tested in the populations the companies intend to sell them too. Without testing the drug in Americans, clinicians won’t know that a drug may be harmful until millions are taking it once its been marketed. Differences in the genetic makeup of different population can cause differences in how we respond to drugs.
For example, genetic variations in the enzyme CYP2C9 between patients of African descent, Asian descent, and European descent cause differences in response to the anticoagulant, warfarin. African Americans tend to require a higher dose and Asians requiring a lower dose than Caucasians to achieve the same effect.
If drug clinical trial is outsourced and only tested in one population, for example the Chinese, their response to the drug might be entirely different than what would be seen in Caucasians or African-Americans. The differences could result in unanticipated toxicities or even death.
(3) US government agencies have limited access to information such as trial sites, investigators, study participants, and research data for clinical trials conducted in other countries. Government regulations and trial monitoring might not be as strict as here in the US. Trial volunteers could be subject to unnecessary dangers, poor practices by doctors, and poor enforcement of regulations.This means that drugs could be approved in the US on the basis outsource data from trials that wouldn’t necessarily meet US standards.
Help keep clinical trials in the US. Whether healthy or ill, consider participating in a clinical trial in your lifetime. Not only is it an opportunity to help the medical community find a new way to fight diseases, but it is an important opportunity to make sure that the response to a drug in a clinical trial is what can be expected once its introduced to the US market.
Outsourcing Clinical Research
Over the years, there has been more outsourcing of clinical trials. Increasingly the populations that are studied during a trial will not be the primary users of the drug products (i.e. the primary market for these products is typically in wealthier nations). The cause for this may be multi-factorial: there are typically financial incentives, decreased regulatory scrutiny, and easier recruitment when clinical research is performed in poorer countries.
For example, it only costs a fraction to conduct the same clinical trial in India as it would cost in the US. Additionally, many countries do not require studies gain approval by an Institutional Review Board or similar agency nor are patients required to have informed consent. It is also notable that recruitment tends to be easier abroad compared to recruiting in the US or Western Europe.
Not only can financial inducement globally exceed what would be deemed as “reasonable” or “fair” compensation in the U.S., for example participants receiving a year’s salary but also the only way that some patients will receive treatments at all is by participating in a clinical trial. Again, the lack of informed consent could also be expected to influence patients’ willingness to participate.
A 2007 New England Journal of Medicine article pointed out that 157 of 509 clinical trials were being performed entirely overseas, often in developing countries. There is a simultaneous proliferation of clinical trials being performed in some of these countries with a decreased number of trials being conducted in the US and Western Europe.
One important consideration is biological differences that cause some patient populations (i.e. Africans) to respond to and metabolize drugs differently than patients of European decent. In other words, as our knowledge of genomic, proteomic, and metabolic differences among patient populations improves, we may soon realize the true implications of not testing drugs in people who are the intended market are much greater than we imagined.
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