It would be hard to argue against the benefits of pharmaceuticals. Their development and use has led to life-prolonging effects such as lowering many people's blood pressure and cholesterol, boosting the immune system of HIV positive patients, and even the remission of some types of cancer. But what happens when these drugs we have so come to depend on contain ingredients, often made in remote regions of the world, that may actually harm us? We may ask ourselves, who is protecting us? And whose job is it to ensure drug safety: the pharmaceutical companies or the government?
Recently, health regulators identified a contaminant found in batches of Baxter International Inc.'s blood-thinner heparin, produced in China, which was linked to serious reactions and nineteen deaths. The contaminant was identified as over-sulfated chondroitin sulfate. Chemically altering the chondroitin sulfate (which is apparently widely available from animal sources) may be cheaper than getting raw heparin from pig intestines. What is still unknown is whether the contaminant was introduced intentionally or by accident -- and whether the contaminant is the cause of the nineteen deaths, hundreds of serious breathing problems, and other reactions reported. One could postulate that the manufacturers were cutting corners by using this cheaper ingredient, but it's too early to rush to conclusions.
Tainted and counterfeit drugs are a growing problem that will not be diminishing anytime soon. The tragic part is that the victims may end up unknowingly taking something with no active ingredients or worse: fake drugs often contain harmful ingredients.
Eighty percent of the active pharmaceutical ingredients of drugs consumed in the U.S. are manufactured abroad. The question is, who is to blame for the tainted drugs? Is it the Food and Drug Administration's fault for inspecting only thirteen of the 566 plants in China that exported drugs to the U.S last year? Is it China's fault for not better policing its manufacturers -- if indeed they should be more involved? Or is it the pharmaceutical companies' fault for outsourcing their production to Third World countries and failing to monitor their practices? A responsible drug company should be making sure that all its suppliers were audited at least once a year to ensure quality and safety, not depend on an underfunded and understaffed government agency.
Clearly, pointing the finger at any one organization will solve nothing. What we need is for the FDA, the pharmaceutical companies, and the foreign government to actively come up with a solution together to both tainted and counterfeit drugs. Outsourcing production to other countries can be beneficial to consumers at home (because it gives us lower priced drugs), but the benefits are negated when safety standards are neglected and we put our health at risk.
Krystal Ford is a research intern at the American Council on Science and Health (ACSH.org, HealthFactsAndFears.com).
See also: ACSH's full-length and condensed reports on Counterfeit Drugs.
