The recent breakdown in the system that allowed Vioxx to remain on the market years after it was identified as a probable cause of cardiovascular problems like heart attack and stroke has many calling for Food and Drug Administration (FDA) reform. However to date Congress as a whole does not see this as a particularly high priority. Several legislative members including Senator Charles Grassley of Iowa and Representative Maurice Hinchey of New York have both been critical of the FDA’s current structure - and lawmakers’ reluctance to move on it.
“The Vioxx example showed that the FDA and Merck were too close for comfort,” Sen. Grassley has said in the past. “Testimony and documents at our Finance Committee hearing showed that the FDA allowed itself to be manipulated by Merck.” Despite this, everyone around the table seems content to keep the status quo - except the patients who have been harmed by Vioxx and other drugs deemed “safe” by the FDA.
“We expected more urgency and we wanted more urgency,” Diana Zuckerman of the National Research Center for Women and Families, told Newhouse News Service (NNS). “There has been a lot of talking, but that’s all.”
And that’s all there is likely to be for some time. NNS also reported that those on both sides in the industry don’t believe it will become an issue until 2007 when Congress reviews pharmaceutical payments to the FDA, used to fund agency drug reviews.
However this debate will likely not touch on the fundamental flaws in the system that allowed Vioxx and other potentially deadly drugs to make it to market. In some instances, it is not even a matter of a drug like Vioxx “falling through the cracks” but a deliberate attempt on the FDA’s part to cover up a drug’s short comings. Many scientists in the FDA (and for that matter Merck) saw that there was a potential risk of cardiovascular problems with the drug, but were told to be quiet about it. There are several whistleblower stories, including a key one from within the FDA in the Vioxx scandal, that helped alert the public to the dangers.
But the FDA is supposed to be the “whistleblower” itself, the ultimate protector of patients from dangerous drugs through a supposedly rigorous testing process. Some have speculated that because many FDA members advance their careers by joining pharmaceutical companies, they regard their work at the FDA as a sort of training camp with potential future employers always watching. It could also be, as Sen. Grassley commented, that the system has allowed the FDA and pharmaceutical companies to work too closely together, instead of at an arm’s length as common sense would require.
Regardless of the shortcomings of the system, it is ultimately the responsibility of the pharmaceutical companies who make Vioxx and other drugs to ensure their safe use. If you have been injured using Vioxx or any other medication, contact South Florida personal injury lawyer David I. Fuchs at 800-570-2858 for a free case evaluation.