STAT News, September 12, 2017. The Food and Drug Administration carefully polices many categories of drugs and devices. But when it comes to software, the agency’s oversight is scanty at best — something that a new study finds is resulting in failure to detect dangerous glitches in software-enabled medical equipment.
Read More »News That Quotes Us & Our Work
We are often quoted in major newspapers and magazines, and on well-respected TV shows, radio programs, and websites where we share our opinion on issues that matter to you and your health. Stay up to date on health news and our take on it by reading the articles in this section.
Will Controversial Bill Cure or Kill Patients?
Who What Why, September 7, 2017. 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.
Read More »EpiPen Maker Failed to Investigate Product Flaws Associated with Patient Deaths, FDA Says
Washington Post, September 7, 2017. “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.”
Read More »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.
Read More »How a Doctor Stirred National Demand for the Bridge Detox Device — Without Solid Evidence It Works
STAT News, August 23, 2017. The Bridge is a wearable device that supposedly helps opioid users deal with painful withdrawals, but the FDA has not yet said whether or not it will work.
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