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  • Book of Matthew: Life, liberty, and the pursuit of healthcare, part 3

    By Bret Matthew
    January 30, 2009
    Section: Impressions


    the_hoot_1-30-09_page_10_image_0001It is no exaggeration to say that the United States Food and Drug Administration (FDA) is one of the most important and most powerful regulatory agencies in the United Sates government. Overseeing a full twenty-five percent of all consumer products sold each year—including food (but not meat and poultry), medicine, cosmetics, radiation-emitting devices, blood products, and medical equipment—the FDA exists to ensure the safety of items that we all need. It should come as no surprise that since the passage of the Federal Food and Drugs Act of 1906, Americans have not just come to rely upon the FDA label guaranteeing the safety of their products; they have come to expect it.

    Unfortunately, the question as to whether or not the FDA deserves the respect and trust of the American people is still up for debate. Recent actions by the agency (not to mention its business practices as a whole) are enough to make one wonder whether it actually has the best interests of the people that it serves at heart. Perhaps you have heard some of these stories…

    In 1998, the FDA approved sucralose for use in artificial sweeteners, the most famous one being Splenda. Although heavily marketed by manufacturer McNeil Nutritionals as a safe alternative to sugar (“it’s made from sugar, so it tastes like sugar!”) the chemical process used to manufacture the sucralose in Splenda involves a great deal of not-so-friendly chlorine. Which means that the popular Splenda, like its artificial sweetener cousin aspartame, could very well be hazardous to our health.

    In 1999, the FDA approved Vioxx, a drug designed to treat osteoarthritis and acute pain conditions. It was a popular drug, prescribed to over 80 million people during its five-year tenure on the market. It was also a lucrative drug, generating $2.5 million in sales revenue for drug maker Merck, its manufacturer. But in 2004, Vioxx was withdrawn from the market when a study revealed that long-term use led to an increased risk of heart attacks. The FDA has since estimated that almost 30,000 people have died of sudden heart attacks as a result of taking the drug.

    In 2004, the FDA approved Cymbalta, an antidepressant manufactured by drug maker Eli Lilly as a replacement for Prozac, the popular (and somewhat controversial) antidepressant which had gone off-patent three years earlier. The FDA did this despite the fact that earlier clinical trials had failed to demonstrate Cymbalta’s effectiveness (and actually exposed several potential dangers), and despite the fact that at the time, the marketing of antidepressants in general was being investigated. Since then, Cymbalta has developed a reputation for increasing suicidal thoughts in patients, as well as causing a host of other painful, disruptive side effects. In fact, it has been reported that at least five volunteers for Cymbalta trials have committed suicide while on the drug. All five had no history of depression, as stipulated in the conditions under which they could participate in the test.

    In 2008, the FDA ruled that high fructose corn syrup is a “natural” ingredient—the term “natural” meaning, “nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food.” This ruling came twenty-five years after the FDA first listed high fructose corn syrup as “Generally Recognized as Safe” for use in food, at which point this sweet, inexpensive syrup began to replace cane sugar on ingredient lists en masse. Although this was surely a boon for American corn growers, scientific research has begun to show links between increased consumption of high fructose corn syrup and the obesity and diabetes epidemics that have plagued the nation in recent years.

    I would like to be optimistic and think that the FDA allowed these dangerous products to enter the market due to simple errors, or that the experts who make the FDA rulings know something that I do not. It is certainly possible.

    But I know that the FDA’s very structure is wrought with inefficiency and conflicts-of-interest. Take pharmaceutical drugs, like the ones I just mentioned. The FDA does allocate some of its resources toward the study of the long-term safety of drugs already on the market, but it dedicates a much greater effort toward the approval of new drugs.

    Why?

    Because the financial security of the agency depends on it.

    It has been estimated that approximately half of the money the FDA spends to regulate pharmaceutical drugs originally came from the pharmaceutical industry, in the form of “user fees.” These fees are part of a deal between the FDA and the pharmaceutical industry that was set up by the 1992 Prescription Drug User Fee Act. Basically, drug companies pay the user fee in exchange for reviews of new medications in twelve months or less. Such an incentive to rush through drug tests means that the FDA does not take near the amount of time that it should in order to properly review new drugs.

    The Bush administration certainly did not help matters with its own policies. The annual funding that the FDA has actually received from the government in recent years is pathetic, considering the scope of the job that it is meant to handle (something like $2 billion—compare that to our $1 trillion military budget).

    Add that to the fact that President Bush made some terrible appointments to the agency, most notably Lester Crawford, who was appointed at the beginning of Bush’s second term to head the FDA. Facing stiff opposition from the very beginning, Crawford resigned after only a few months on the job, and actually faced criminal charges from the Department of Justice after it became known that he had lied about his ownership of several stocks in companies that the FDA was supposed to be regulating.

    So conservative policies did not bode well for the FDA. But luckily for us, a conservative politician no longer occupies the White House. President Obama has promised to reverse many of Bush’s policies in his plan for a massive overhaul of the nation’s healthcare system.

    But we cannot say we have a good healthcare system until we can safely buy consumer goods without fear of harm. Will President Obama and the Democratic Congress regulate the FDA and end the corruption that has shrunken its capacity to function? Will they properly fund the agency so it can operate effectively without having to rely on user fees? Will they appoint competent men and women to run it correctly?

    I hope so. Because I believe that the FDA can be a force for good, and I would very much like to see its seal of approval have meaning. Right now, it does not


    More posts by Bret Matthew