The Safe Patient Project is a Consumers Union campaign focused on eliminating medical harm, improving FDA oversight of prescription drugs and promoting disclosure laws that give information to consumers about health care safety and quality.
In October of last year, Terri wanted to become involved in her state’s special election in a real way. With each passing day, she became angrier about the TV ads the drug companies were constantly running to defeat real drug price reform…
Medical Devices & Drugs
Americans have suffered and lost their lives because they are not given ALL information about risks by either manufacturers or the FDA. Pharmaceutical companies should be accountable for safety problems, and not keep drug risks hidden from the public. Medical device companies should respond to malfunctioning implants.
Medical Device Legislative Information
Consumers Union Documents
- Consumers Union’s comments of FDA Reclassification of Metal on Metal Hip Implants
- Real People, Real Stories: Diane’s knee replacement story
Diane of Longmont, CO shared her knee replacement story with Consumers Union. Diane had a terrible experience with her initial knee replacement and is worried about what the future holds.
- Consumer Reports: FDA cracks down on all-metal hip replacements
Manufacturers who want to keep selling all-metal hips will have to prove that they’re safe and effective, according to proposed new rules from the Food and Drug Administration.
- Consumer Reports: Where high drug costs hide
Before filling your prescriptions, beware of these 5 traps
- Consumer Reports: Off-label drug prescribing: What does it mean for you?
Doctors often prescribe medication to treat problems the drugs aren’t officially approved for, which can be good—and bad—for patients
Consumers Union News Releases
- Consumers Union Urges FDA To Require Safety Testing of Metal on Metal Hips and Other High Risk Implants
Consumers Union urged the U.S. Food and Drug Administration today to adopt a proposed rule requiring metal hip implants to be reviewed through the agency’s premarket approval (PMA) process to prove that the devices are safe and effective.
- FDA Proposes Unique Device Identification Regulations for Medical Device
New system could help consumers of implantable life-sustaining devices access recall and other safety information about their specific device with a unique identifier system.
- Senate to Vote on Final FDA User Fee Bill As Early As Today
Bill Makes Some Improvements To Medical Device Oversight But Falls Short of Giving The FDA The Tools It Needs to Protect Patients
- House and Senate Leaders Announce FDA User Fee Act Compromise Bill
Bill Includes Patient Safety Provisions From Senate-Passed Version And Some Measures Opposed By Consumer Groups; House Vote On FDA User Fee Bill On Wednesday, June 20
- CU pushes medical device reforms in final FDA bill
Consumers Union urges lawmakers to adopt stronger patient safety provisions from Senate version of the FDA User Fee Act
Blog Posts
- We’re live blogging at Selling Sickness!
Consumers Union’s Safe Patient Project is here in DC at the Selling Sickness conference, and we’ll be live blogging speaker panels while we’re here. Just come back to this page to see our live updates.
- Heartbreaking news: Child discovers 2nd recall connected to her defibrillator
9-year-old child, Avery de Groh, faces a scary situation: having a recalled defibrillator which the family found out by accident. This is the second time that Avery’s family has been affected by a recalled defibrillator. Last year, Avery’s mother, Molly, shared her daughter’s story about how she was shocked by a defective defibrillator at age three and thought monsters were attacking her. Her device was later recalled by the manufacturer.
- Advocates share medical device dangers in presentation at University of Texas
Medical device safety advocates, Lana Keeton and Joleen Chambers, share their personal stories of medical device harm and the need to be informed, in a presentation at the University of Texas in Austin.
- Selling Sickness conference is putting “People Before Profits”
We are thrilled to co-sponsor and attend the upcoming Selling Sickness conference in Washington DC, co-organized by long-time drug safety advocate Kim Witczak.
- Holiday in the hospital? Stay safe!
If you have to enter a hospital over the holidays, we have some advice on how to stay safe in there.
News Articles
- J&J Will Stop Sales of Metal-on-Metal Hip Replacements Source: Bloomberg (Friday May 17, 2013)
Bloomberg reports: “Johnson & Johnson (JNJ), the world’s biggest maker of health-care products, said it will stop selling metal-on-metal and ceramic-on-metal hip replacements as demand wanes for the devices and U.S. regulators seek new rules.”
- J.&J. Unit Phasing Out All-Metal Hip Devices Source: New York Times (Thursday May 16, 2013)
NY Times: “The orthopedic unit of Johnson & Johnson said Thursday that it was phasing out production of all-metal replacement hips, a move reflecting an industrywide trend to abandon the once widely used implants because of high early failure rates.”
- J&J will abandon metal hip replacement sales Source: Fierce Medical Devices (Thursday May 16, 2013)
J&J announced it will discontinue selling its metal-on-metal and ceramic-on-metal hips by the end of 2014. Consumers Union has voiced major patient safety concerns with metal-on-metal hip implants after hearing from many patients with metal-on-metal hips who faced problems and/or became disabled.
- Strengthening our National System for Medical Device Postmarket Surveillance Source: FDA (Monday April 1, 2013)
Update and next steps.
- Strengthening Our National System for Medical Device Postmarket Surveillance Source: FDA (Saturday September 1, 2012)
The report includes plans for establishing a unique device identifier and promotion of registries for tracking devices.
Research and Reports
- Patient Safety America Newsletter (April 2013) Source: Patient Safety America (Sunday March 31, 2013)
Summary by John James: “Changes are long overdue in American healthcare as pointed out by the Institute of Medicine and National Research Council in their new book “The US health Disadvantage Relative to Other High-income Countries.” My first newsletter article attempts to summarize this report. In the second article I discuss the risks associated with sleeping pills. The third article considers legislation that often has collateral damage. The fourth involves one doctor’s view of how he was led into care that was not patient centered. My next two articles deal with mental health: 1) As we age, we all fear the loss of mental capabilities, but a new study has linked mid-life fitness with a reduction in the risks of dementia. 2) Young people often do not have access to mental health facilities as pointed out by experts writing in the JAMA. The next articles deal with unintended death from pharmaceuticals and with loss of confidence in drug companies. The newsletter concludes with a short piece on the vanishingly small value of robotic surgery for those who might need a hysterectomy.”
- Patient Safety America Newsletter (March 2013) Source: Patient Safety America (Monday March 4, 2013)
John James, Ph.D., Patient Safety America: “This month I’ve tried to put some important things in perspective for you. Ben Goldacre’s book called “Bad Pharma,” which I reviewed, is a worth-while read. Gun violence is compared with “medical violence” as far as they affect our children’s lives. The cheap, effective medical care received in Cuba is summarized as a lesson for us, and then I pound on the dangers of drugs and the unstoppable overpricing of medical care in our country. Finally, you’ll learn what post-hospital syndrome is and how to manage it to remain out of the hospital.”
- FDA Safety Communication: Metal-on-Metal Hip Implants Source: FDA (Thursday January 17, 2013)
Today the U.S. Food and Drug Administration (FDA) issued a Safety Communication on metal-on-metal hip implants which includes recommendations on imaging a patient with a metal-on-metal hip implant.
- NEJM Perspective: The 510(k) Ancestry of a Metal-on-Metal Hip Implant Source: New England Journal of Medicine (Thursday January 10, 2013)
Using FDA documents obtained from the agency’s database and Freedom of Information Office, authors traced the ancestry of the ASR XL back more than five decades, through a total of 95 different devices (including femoral stems), including 15 different femoral heads and sleeves and 52 different acetabular components (see figure, and the interactive graphic, available with the full text of this article at NEJM.org).
- AARP's drug savings tool: Helping you get the most value for your healthcare dollar Source: Consumer Reports (Saturday December 1, 2012)
Have you ever wondered if the medication you’re taking is really the best one for your condition? Is there a less expensive, but equally effective medication you can use instead? Or is there a comparable drug with fewer side effects? AARP’s Drug Savings Tool, powered by CR Best Buy Drugs, can help you get the most value for your prescription drugs and learn more about the medications you take.
Activists
We first contacted Laurie Yorke of Clark, NJ last year after we saw her on-line support group for those that have suffered from the side effects of Paxil and other anti-depressants. Three years ago, Laurie almost lost her then 15 year old son, Ryan due to a reaction to a off label use of Paxil. When Ryan started taking Paxil there were no warnings about suicide, aggression or personality changes. After a year on this drug she watched him change into someone she didn’t recognize. He had gone from a social, A student to a lethargic, confrontational, failing student. It was during that time that Ryan attempted to take his own life. Desperate to find out what was happening to her son, Laurie started doing her own research on the Internet…
Laurie of Clark, New Jersey
To Delay is Deadly
98,000 people die each year needlessly because of preventable medical harm. Efforts to reduce this are few and fragmented. With little transparency and no public reporting (except where hard fought state laws now require it), scarce data does not paint a picture of real progress.
In this report (PDF) we give the country a failing grade on progress on select recommendations we believe necessary to create a health-care system free of preventable medical harm.