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Posts Tagged ‘FDA’

Woody Guthrie’s Birthday and the War on Cynicism

In our fight for a better quality of life for all Americans, we need storytellers. We need to reach people through personal anecdotes, through editorial cartoons, through songs. We need to arm people with narratives of what is possible, so that together we may be successful in spurning the cynicism that supports the status quo and disillusions the disempowered. And few have done this better than the man who would have turned 100 years old tomorrow: songwriter and American folk hero Woody Guthrie.

But what do Woody’s writings have to do with science? As it turns out, plenty. Read More

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The Future Health of Scientific Integrity is at Stake in New FDA Law

The news these days has rightly focused on the Supreme Court’s landmark decision on access to health care.  But with scant media attention, Congress on June 26 sent a bill to the President that is just as important  to the health and well-being of each and every American family, and the future of scientific integrity at the Food and Drug Administration. Read More

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We Found Independent Experts—the FDA Can Too

Pharmaceutical and medical device companies, and some in Congress, argue that it’s difficult to find independent experts to serve on FDA’s scientific advisory committees due to strong financial conflict of interest standards.

Our experience proves otherwise. Read More

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New Report Details What Should Happen When Scientists at FDA Disagree

Should scientists at the Food and Drug Administration be able to have honest disputes with their colleagues about the science behind a drug or medical device approval decision? Or should they keep quiet about their concerns, preferring not to rock the boat? Read More

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For Sara, Faulty Medical Device Leads to Unnecessary, Invasive Surgery

Along with Gwen, Elsa, and Henry, another UCS supporter shared his family’s experiences with unsafe drugs and medical devices: John M’s daughter, Sara, has had needless complications with medical devices in her heart. Read More

Categories: Scientific Integrity  

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Study: FDA is Faster than Europe, Canada in Drug Approvals

In the New England Journal of Medicine this week, scientists from Yale University published research finding that the Food and Drug Administration approves drugs faster than its counterparts in Canada and Europe. (Media coverage is here and here.) The study reinforces the fact that FDA can approve drugs with relative speed while putting the safety of Americans first. Read More

Categories: Scientific Integrity  

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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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