After sharing the personal experiences of two separate UCS supporters—Gwen and her mother, Maxine and Elsa and her husband, Dan–with drug and device safety, I’ve heard from others who are also brave enough to share their stories with us. Henry H.’s tale about his metal on metal hip replacement is particularly touching, showing how a faulty medical device can have consequences not just for the victim but for his entire family. Read More
April 25th, 2012
April 13th, 2012
Experts on FDA advisory panels with financial conflicts of interest can influence the approval of a drug in multiple ways, not only by voting to approve a drug but also by dominating the discussion and pressuring other panelists. In the case of the popular contraceptive drug Yaz, four scientists with financial conflicts of interest were enough to push the vote in favor of the drug, with significant consequences for some women. Read More
April 11th, 2012
Yesterday, I shared the story of a UCS supporter whose family had experienced tragic consequences when unsafe drugs were allowed on the market. But drugs and medical devices, when adequately tested and monitored, do have the potential to vastly improve one’s health. For Dan O. of Norwalk, CT, medical advances in the treatment of the coronary system have been lifesaving.
April 10th, 2012
The consequences of unsafe drugs and medical devices are real—and nobody knows that better than Gwen B. of West Sacramento, California. We talked a few days ago after she responded to a UCS action alert with a story about her mother, Maxine, and I was moved enough to want to share her family’s story with you. Read More
April 3rd, 2012
In today’s New York Times, Gardiner Harris describes tensions between the FDA, Congress and the White House regarding the agency’s attempts to inform and protect the public. It’s an incredible article that helps demonstrate the pervasiveness of both political and corporate pressure on the agency, and how those who do not have scientific training in public health attempt to take decision-making authority on what should be scientific issues away from those who do.
March 27th, 2012
So far, we’ve provided general background on the FDA’s responsibility to ensure the safety and efficacy of prescription drugs. We have explored how the drug approval process works and examined what happens when the drug safety system breaks down. And we have looked at the importance of truly independent scientific advisory committees to the FDA’s ability to protect the public. Read More
March 23rd, 2012
As I’m sure you’ve noticed, we have been blogging quite a bit recently about the FDA. This corresponds to legislation that would determine how the FDA approves and monitors drugs and medical devices. But why have we been so focused on reducing the number of FDA advisory panel members who have financial conflicts-of-interest? Read More
March 21st, 2012
While there’s a wealth of scientific expertise inside the FDA and other federal scientific agencies, FDA’s scientific staff often rely on the advice of experts outside the agency to help them decide whether to approve a new prescription drug or medical device, or to recall a product or issue stronger warning labels when there are safety problems. Read More
March 19th, 2012
In a previous blog post, I explained the FDA’s complex process for approving drugs and medical devices. However, in many cases, pressure from commercial interests has broken down this process. The approval and subsequent recall of Vioxx took its toll on thousands of Americans, including my own father.