Overcoming Pain

Why people experience chronic pain, and the power they have to de-intensify it

Outsourcing Drug Development

Maybe this halter top is not so sexy, even with the discount.

They stopped searching for dead bodies in Bangladesh earlier this month, those victims of a disaster, killed while making clothes they themselves would likely never wear even had they not met an untimely death. Many say these tragedies will continue; the developed countries want the cheap clothes made by the developing countries.

But outsourcing goes beyond that halter top just marked down 40% at H & M.

Many pharmaceutical companies are conducting clinical trials outside the United States, often in developing countries; and many countries are seeking these trials, as they can add significantly to the economy. Of course, there are those who protest that such foreign study subjects are putting themselves at risk, taking drugs that they themselves would likely never use should those medicines ever make it to the market. Another concern is that it could be that the results of those foreign studies are not applicable to the patients who are most likely to use the drugs being studied

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Maybe this halter top is not so sexy, even with the discount.

An example of a recently approved drug that had seemingly differential outcomes in different parts of the world is belimumab for the treatment of lupus. According to a briefing for an FDA committee, the efficacy of belimumab was questioned in certain populations, including Africans and African-Americans. In fact, there was noted “an inconsistent efficacy trend across different geographical regions of the world with numerically smaller separation of efficacy measures between placebo and belimumab for patients from the United States and Canada compared to some other regions.”

In other words, results from subjects studied outside of the United States may not be generalizable to the patients who need a given treatment in the United States.

Outside of the United States, even the “thought leaders” associated with a certain illness might not know much about the pharmacogenomics of other populations, and maybe even less about the severity of a disease and the local treatment practices. These variables can impact the safety and effectiveness of drugs being studied, making it all the more difficult to transfer in a safe and effective manner the ideal dose of the new drug when it comes to market. (For example, in China and Japan, many of the traditional immunosuppressive and biological drugs are used at much lower dosages compared to the dosages prescribed in the United States.)

Analyses of data from foreign studies can show dramatic variation in both treatment and placebo responses in different parts of the world. One theory is that patients in, say, an undeveloped country with little access to health care may become highly anticipatory if enrolled in a clinical trial—the thrill powering the placebo effect. And the clinical investigator in that part of the world may power the placebo effect through an overwrought approach to being, well, an investigator.

So, is conducting clinical trials abroad worth it? Maybe.

For not all drugs will have different effects on different populations, and the inability to predict the pharmacogenomics of this or that treatment is reason enough in the minds of many researchers to pursue clinical studies abroad—even though there are many other reasons:

• Access to a global population in the billions, as opposed to the 300 million in the United States, allowing for accelerated patient recruitment.

• A 2008 article in the Harvard Business Review noted that the discovery and development of new drugs consumes over ten years and over $1 billion; by conducting half of the clinical trials outside expensive regions such as the United States and Western Europe, in, for example, India and South America, a pharmaceutical company could save hundreds of millions of dollars.

Just as certain leaders in the garment industry have proposed investment in foreign factories to protect the health of workers, so international observers are encouraging drug companies to not simply conduct a study for a few months and then leave: They ask that patients who have participated in their studies be respected, recognized for the risks taken, and provided with options that allow for continued healthcare in some fashion.

The outsourcing of drug studies to certain economically deprived regions of the world does not have to be exclusive of the exporting of a caring attitude to those same areas.

Mark Borigini, M.D., is a board-certified rheumatologist who has devoted his career to treating illnesses that cause chronic pain and disability.

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