The mission of Washington Advocates for Patient Safety (WAPS) is to promote accountability, quality, safety, and responsibility in patient care. As the voice of patients, their goals are to eliminate medical errors and harm and to save more lives.
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.
Consumers Union Documents
- Consumer Reports investigation: Are too many kids taking antipsychotic drugs? Source: Consumer Reports (Wednesday December 11, 2013)
Consumer Reports investigates antipsychotic drug use in kids. Use is climbing despite questions about how safe the drugs are and how well they work.
- CR poll: Americans want safer medical devices Source: Consumer Reports (Tuesday March 20, 2012)
Consumer Reports: Americans support stricter safety standards for medical devices, according to a new Consumer Reports poll. More than eight of 10 people in the survey said it was more important to prevent safety problems in the devices than it was to encourage innovation or avoid delays in getting them to market.
- Consumers Union's comments of FDA Reclassification of Metal on Metal Hip Implants Source: Consumers Union (Thursday April 18, 2013)
- Real People, Real Stories: Diane's knee replacement story Source: Consumers Union (Friday March 29, 2013)
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 Source: Consumer Reports (Friday January 18, 2013)
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.
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
- House Voting Today on FDA Reform Act
House Bill Is Weaker Than Senate-Passed Version and Fails to Include Important Patient Safety Protections
- 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.
- Inappropriate antibiotic use in emergency rooms not decreasing in adults Source: Antimicrobial Agents and Chemotherapy. (Thursday January 9, 2014)
“An analysis of emergency room (ER)visits over a 10-year period finds that while inappropriate antibiotic use is decreasing in pediatric settings, it continues to remain a problem in adults, according to an article published ahead of print in Antimicrobial Agents and Chemotherapy.” Inappropriate antibiotic use can lead to the development of antibiotic resistance.
- Hoping for Financial Compensation, Safer Drugs from Big Pharma in 2014 Source: Drug Watch Radio (Thursday January 2, 2014)
Drug Watch Radio includes CU’s Safe Patient Project campaign in its New Year’s wish list. You can listen to our interview on Drug Watch Radio here: http://www.drugwatch.com/radio/consumer-reports-interview-lisa-mcgiffert/
- In A Major Shift, Medicare Wants Power to Ban Harmful Prescribers Source: ProPublica (Monday January 6, 2014)
ProPublica reports that Medicare has issued a proposed rule that would give the agency the “authority to kick out physicians and other providers who engage in abusive prescribing. It could also take such action if providers’ licenses have been suspended or revoked by state regulators or if they were restricted from prescribing painkillers and other controlled substances.”
- Seattle Times video: How to make millions off a drug for a rare disease Source: Seattle Times (Friday January 3, 2014)
Seattle Times investigation of how drug companies are making millions by marketing off label uses.
- How a drug for few patients was turned into $81 million in sales Source: Seattle Times (Saturday November 9, 2013)
“Orphan drugs, approved for rare diseases, can become big sellers. One Seattle biotech’s drug provides a case study in how the chase for profits can turn into accusations of unlawful marketing.”
Research and Reports
- 2014-2015 Targeted Medication Safety Best Practices for Hospitals Source: ISMP (Thursday December 12, 2013)
Institute for Safe Medication Practices report on medication safety best practices for hospitals.
- 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).