Will Controversial Bill Cure or Kill Patients?

Diana Zuckerman, president of the National Center for Health Research, points out that drug companies rely on a three-phase clinical trial process to gain FDA approval for their products. If RTT siphoned off patients with life-threatening illnesses from clinical trials, particularly for trials of medications serving limited populations with rare diseases, drug companies might find it even harder to enroll enough patients to complete them. And health insurers will not pay for drugs that lack FDA approval.

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EpiPen Maker Failed to Investigate Product Flaws Associated with Patient Deaths, FDA Says

“It may well be a very small number, relatively speaking, of EpiPens that are likely to be problematic, and it may be that those have been recalled. But the parents and patients don’t know that,” Zuckerman said. “This is a product where you don’t know, until you use it, whether it works or not. I think it’s safe to say no patient — and no parent — wants to find out the hard way that the product that they have isn’t effective.”

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What You Need to Know About Essure

Our Bodies Ourselves, August 23, 2017. The “Ah-ha” moment came when several women told us that they had participated in clinical trials the FDA used as the basis for its approval. They told us that their reports of unrelenting, debilitating pain and other serious side effects were not included in the clinical trial data. Why? They said they were told by the doctors and nurses involved in the studies that the side effects were not caused by the device.

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