Corrupt practices and the ineptitude of the FDA continues to place millions of Americans at risk.
By Micah Hanks
In spite of Obama’s sweeping Health Care Reform plan that passed the House earlier this year, it’s no secret that the medical services required by most Americans today are badly in need of a reboot. Costly treatments and medications are troubling, especially for senior citizens, and reports of inefficiency and risk associated with the drugs they’re being prescribed provide little fiscal incentive. But to be honest, in some cases the drugs being prescribed aren’t even the right match for the patient’s condition, one of many circumstances that expose the flaws and oversight in the Food and Drug Administration’s judgment about what gets approved for human consumption.
In his weekly newsletter, Dr. William Douglass, M.D. recently wrote about a rare condition called pulmonary arterial hypertension (PAH), a form of high blood pressure that settles exclusively in the lungs. “It’s very serious, and very fatal,” Douglass wrote. “But because it only affects 600 kids a year, Big Pharma has little interest in developing a real cure.”
According to Douglass, Pfizer, the world’s largest pharmaceutical research company, was asked to try using an existing drug to treat the condition instead. The drug selected, sildenafil, is better known by its commercial name: Viagra. Trial studies where the drug has been administered to children to treat PAH condition have been mixed, with many patients garnering little or no benefit from the medication at all. Worst of all, Douglass points out that Pfizer, by electing to test an existing drug–rather than take time and money to develop new treatments for special-needs children–are awarded a hefty six-month extension on their patent. So in the end, they not only skip having to spend on developing new drugs by administering existing medications; they benefit from it.
“Hundreds of kids involved in this trail are risking this drug’s known side effects,” Douglass wrote, “including blindness, hearing loss, and even those infamous painful erections.” Is Viagra the kind of medication you want your children taking?
This is only one instance where the FDA’s oversight allows for potentially harmful treatments to be administered to Americans. A recent TIME article, “Is the FDA On Drugs?”, examined the way scientists and executives with the drug company GlaxoSmithKline (GSK) met with the FDA in 2007, providing misleading evidence that Avandia, a drug used in the treatment of diabetes, showed no severe risks associated with myocardial ischemic events. The truth, however, was quite different: Avandia was found to be linked with a 43 percent increase in heart attacks, when compared alongside other medications. Even worse, GSK’s own studies concluded that a rise in cardiac risk had been associated with the drug, as noted by an analysis by the company’s Global Safety Board. GSK stood to gain millions, and after lobbying to keep the drug on the market, the FDA granted approval, at the potential detriment of millions of Americans suffering from diabetes.
Can capitalism be blamed for the greed that allows giant corporations to profit at the expense of the common man? Inevitably, some will argue that this is the case; but in truth, no market is capable of freedom when government-run organizations like the FDA are in ultimate control of a system that is repeatedly gamed by those seeking the almighty dollar. Numerous complaints have been leveled against the FDA in recent years, alleging that they have shown favoritism to larger pharmaceutical companies in preventing the release of less expensive, generic-brand alternative medications. In fact, a 2006 independent assessment of the FDA’s drug approval practices referred to the organization as “corrupted and distorted by current FDA managers, thereby placing the American people at risk.”
If regulation were properly implemented, it would be holding those companies who placed profit above public safety accountable, not granting them leeway to cause further destruction under the guise of helping those in need of affordable, reliable, and safe medications. Don’t blame capitalism for this blatant disregard for public health and safety; blame the enabling corporatist entities working in collusion with these groups which, in a morally just market system, would not exist. In their absence, we’d likely be a happier and healthier populace, and the rule of law would hold those who sought to profit from their unethical practices accountable for their actions.
Image by David Goehring via Flickr.
