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Posts Tagged ‘FDA’

Senate Does the Right Thing for Whistleblowers – So Close to a Win-Win-Win

At last, a bit of good news and a glimmer of hope from Congress. Last Tuesday evening (May 8), the Senate unanimously approved S. 743, the Whistleblower Protection Enhancement Act. Read More

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New Executive Order Could Limit Ability of U.S. Science Agencies to Protect the Public

It is ironic that 50 years after the drug thalidomide was found to have caused serious harm to tens of thousands of babies in Europe and Great Britain, but not the U.S., both the Administration and Congress are backing efforts that could unravel the safety net and erode the power of American agencies to protect public health and safety. Read More

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The Human Cost of FDA Decisions: A Faulty Hip Replacement Disrupts a Young Man’s Life

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

Categories: Scientific Integrity  

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How Conflicted Experts Can Sway FDA Drug Approval Decisions: A Case Study on Yaz

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

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The Human Cost of FDA Decisions: For Dan and Elsa, Life Depends on Safe Medical Devices

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.

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The Human Cost of FDA Decisions: For a Midwestern Family, A Breakdown in Drug Safety Hits Home

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

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New Allegations of Political and Corporate Pressure on FDA

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.

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Money Talks, and What It’s Saying May Harm the FDA

Any way you look at it, $700 million is a lot of cash. That’s the amount that industries regulated by the FDA have spent since 2009 lobbying Congress and the Executive Branch. That investment is paying off as Congress now considers must-pass legislation that governs how the FDA uses science to evaluate prescription drugs and medical devices. Read More

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Three Myths about How the FDA Drug Approval Process Works

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

Categories: Scientific Integrity  

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Five Reasons Congress Should Support Strong Conflict-of-Interest Standards at FDA

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

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