Feds to crack down on those who fail to report clinical trials - Politico Pro, September 16, 2016
Drug companies and research institutions will have to publicly report more clinical trial data, including results that show their products or experiments failed, under new policies rolled out Friday by HHS. But NCHR president criticizes their decision not to provide summaries of treatment results that patients can understand. Read more…
Doctors Downplaying Drug’s Suicide Risks Attract FDA’s Scrutiny - Bloomberg, September 13, 2016
The U.S. Food and Drug Administration has a message for doctors: The money you’re taking from pharmaceutical companies may be clouding your judgment. NCHR president Dr. Diana Zuckerman points out questions about the accuracy of safety data submitted by Pfizer about Chantix, the smoking cessation drug.
Medical Devices Approved Using Low-Quality Data Affect Medicare Costs - Bloomberg BNA, September 8, 2016
High-risk medical devices are sometimes approved using low-quality clinical data and this increases Medicare costs, a member of a Medicare congressional advisory panel said Sept. 8. The session may portend a deeper examination of the device industry’s practices, which could cause Congress to change payment rates for devices and related services, as the commission’s recommendations are fairly influential. Commissioner Rita Redberg, a cardiologist at the University of California San Francisco Medical Center, called for further MedPAC examination of how to push Medicare to more broadly consider quality over an entire episode of care when deciding whether to cover a device. NCHR’s president Dr. Diana Zuckerman said “I agree completely.”
21st Century Cures Act: Yes or No? No: Act’s promise of quick cures is a brew of ultra-hype mixed with snake oil - Chicago Tribune, By Diana Zuckerman
Imagine that you or someone you love has a potentially fatal disease with no proven treatment, but there is a new experimental treatment available.
Would you rather be given that treatment for free by a top physician who carefully monitors your treatment as part of a clinical trial to study whether it works, or, would you rather pay more than $100,000 a year for the same experimental drug and hope your doctor gives you the right dose?
Selling Side Effects: Big Pharma’s Marketing Machine - DRUGWATCH July 2016
Convincing people they are sick and need a drug is a multi-billion dollar industry. In 2015, Big Pharma dropped a record-breaking $5.4 billion on direct-to-consumer (DTC) ads. And it paid off for Big Pharma. Americans spent a record $457 billion on prescription drugs. The U.S. and New Zealand are the only countries where DTC is legal. Americans also pay more for drugs and devices than any other country. Behind the drug and device ads saturating TV, radio and digital media are hidden costs and devastating side effects that companies don’t advertise. “Americans tend to think newer is better. If it costs more, therefore it’s better. If it’s new and it costs more, then certainly it is better,” Diana Zuckerman, president of the National Center for Health Research, told Drugwatch. “They sometimes…
Lack of African Americans in breast cancer studies results in less effective treatment and higher death rate - The disparity in breast cancer mortality between Black and White women has widened in our country’s most populated states. Cancer experts usually conclude that although there have been advances in breast cancer screening, prevention and treatment, these advances have not been equally available to Black and White patients.