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Failure to Consider the Risks

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Americans consume more medications than any other population on earth. And they’ve become increasingly aware that while medications are prescribed for certain benefits, the risks involved must be taken seriously. The economic stimulus legislation created a council of up to fifteen federal employees to coordinate the research and to advise Congress and the President how to spend the money. According to the New York Times, $1.1 billion will permit researchers to compare drugs, medical devices, surgery, and other methods of treatment. But if the government measures only the benefits of different treatments without comparing the risks as well, how does that help the American people in the long run?
A study published in the April issue of Spine reported that 1 in 5 patients who died after having back surgery (spinal fusion or lumbar fusion) had complications linked to the painkillers that were used to help relieve lower back pain. The study further reported that middle-aged men with degenerative disc disease ran seven times the risk of painkiller poisoning when compared to other surgical patients. Painkillers—non-steroidal anti-inflammatory drugs in particular—have now been linked to increased blood pressure, reduced ability of broken bones to heal, gastrointestinal bleeding, and increased risk of heart attack.
An injectable diabetes drug, liraglutide, touts the benefits of controlling blood sugar and reducing weight. Yet even after learning that the drug caused cancerous tumors in lab animals, the FDA approval panel arrived at a tie vote (six to six) on the question of safety! And Novo Nordisk, the drug’s manufacturer, says they are “confident” that the drug will be approved in a few months.
Up to 51% of liver failure in this country is linked to acetaminophen poisoning. According to the American Liver Foundation, acetaminophen (a main ingredient in over-the-counter pain relievers) is the most common cause of acute liver failure; other causes include reactions to prescription, over-the-counter, and illegal drugs as well as viruses, such as viral hepatitis
It is time federal regulatory agencies—the FDA in particular—stop looking for imaginary risks in supplements and start looking at drug risks across the board. The risks involved with prescription drugs, over-the-counter medications, and medical devices take a sobering toll on Americans’ health.
A 1998 study revealed that more than two million American hospitalized patients suffered a serious adverse drug reaction (ADR) within the twelve-month period of the study and, of these, over 100,000 died as a result. The researchers found that over 75% of these ADRs were dose-dependent, which suggests they were due to the inherent toxicity of the drugs rather than to allergic reactions. The research team concluded that ADRs are now the fourth leading cause of death in the United States after heart disease, cancer, and stroke. Some data suggests that medical care in general is the leading cause of death (see the documentary film Death by Medicine by Gary Null and others, to be published as a book in early 2010).
FDA-approved medications and medical devices come with considerable risks, some of which are deadly; issuing occasional “black box warnings” are simply not good enough. It is time to reform the FDA. Acknowledge the risks as well as the benefits of prescription drugs, medical devices, and surgical procedures in order to fairly assess our treatment options. Demand that medicines such as homeopathic remedies which have stood the test of time and have an enviable safety record be given the same consideration as risky prescription options.

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