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: What can I do if the pharmacy gives me the wrong drug? Source: Consumer Reports (Thursday May 8, 2014)
Tips from Consumer Reports on avoiding medication errors at the pharmacy.
- Consumers Union comments to FDA regarding direct to consumer TV ads Source: Consumers Union (Monday April 21, 2014)
Consumers Union’s Safe Patient Project submitted comments to FDA about a proposed rule to study limiting the list of drug side effects in a TV drug ad. We have concerns about the possibility of limiting major drug side effects in drug ads, and believe the FDA proposed study has design flaws.
- 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)
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
- Rethinking the use of Morcellators on Women
A morcellator is a medical device that seems like it was developed in medieval times as an instrument of torture. But it is actually marketed and used to grind up tissue during laparoscopic hysterectomies and uterine fibroid removal. It becomes problematic if the tissue being shredded is cancerous. The FDA recently issued a safety alert stating, “Morcellating these tumors can spread cancerous tissue internally and significantly worsen the odds of long-term survival.
- Patient safety activists react to USA Today story on seniors and Rx drugs
This week’s USA Today story about the problem of overprescribing serious narcotics and pain killers to seniors touched a nerve with Consumers Union’s Safe Patient Project activists. According to the story, “hundreds of thousands of the nation’s seniors are misusing prescription drugs, including narcotic painkillers, anxiety medications and other pharmaceuticals, for everything from joint pain Continue Reading
- 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.
- A Loophole For Industry To Promote Off-Label? Source: Kim Witczak, Selling Sickness (Tuesday May 13, 2014)
Kim Witczak writes about a “new potential loophole being created by the FDA with its new guidance around distribution of reprints from articles that appear in medical/scientific journals.”
- USDOJ: Astellas Pharma US Inc. to Pay $7.3 Million to Resolve False Claims Act Allegations Relating to Marketing of Drug Mycamine Source: Department of Justice (Wednesday April 16, 2014)
DOJ: “Pharmaceutical company Astellas Pharma US Inc. will pay $7.3 million to resolve allegations that it violated the False Claims Act in connection with its marketing and promotion of the drug Mycamine for pediatric use, the Justice Department announced today. Astellas Pharma US Inc., located in Northbrook, Ill., manufactures and sells pharmaceutical drugs, including Mycamine.”
- Double Dip: Doctors Paid to Advise, Promote Drug Companies That Fund Their Research Source: ProPublica (Tuesday March 25, 2014)
Research has been seen as less objectionable than other forms of interactions with drug companies, but 10 percent of researchers have multiple ties among the nine companies ProPublica analyzed. That raises questions about doctors’ impartiality.
- Is All That Rambling Too Confusing?? Fda Thinks So. Source: Selling Sickness (Friday March 21, 2014)
Kim Witczak, co-founder of the US Selling Sickness conference says: “Direct-to-consumer advertising of prescription drugs shouldn’t be allowed, but since it is, I believe that the warnings should be strengthened, not reduced.”
- 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.
Research and Reports
- Patient Safety America Newsletter (November 2013) Source: Patient Safety America (Thursday October 31, 2013)
Summary from John James: “The devastation wrought by hurricane Sandy leaves us full of empathy for those who lost loved ones and homes. When disaster unfolds suddenly, we notice it as the news media graphically magnifies the events on our TVs. The disaster that comprises much our medical industry quietly unfolds as medical errors occur in hospitals spread across the nation, and no one is there to produce graphic images of the death and suffering. In an attempt to display some of the suffering, my November newsletter begins with a review of the book “Unaccountable” by Marty Makary, MD. I was not fully aware of the endemic nature of the dangers lurking in hospitals.
The first two articles deal with medical errors – the first on diagnostic errors and the second on errors of omission. On page 3 I take a look at recent misdeeds of big Pharma, and then deal with ethical issues associated post-marketing drug testing on patients. A business model suggests that providers should start giving us what we really want – health – not medical care. Finally, we have a look at why hospital prices continue to escalate. I hope you find these stories informative.”
- Patient Safety America Newsletter (October 2013) Source: Patient Safety America (Wednesday October 2, 2013)
Summary from John James: “These are frustrating days in our country because it seems that anyone left in the middle ground on major political issues is rare, or at least they dare not speak. As we chide Congress for its ineptness, we must acknowledge that we put those people there, and in most cases they reflect what we want.
This month I was honored to have my new estimate of harm to hospitalized patients, which was published in the September issue of the Journal of Patient Safety (http://journals.lww.com/journalpatientsafety/pages/articleviewer.aspx?year=2013&issue=09000&article=00002&type=abstract), picked up Marshall Allen of Pro Publica (http://www.propublica.org/article/how-many-die-from-medical-mistakes-in-us-hospitals). He brought validity to my estimate by asking MDs in the patient safety community what they thought of my work. I have marked his and other sources that wrote about the new estimate with an asterisk in my “SitesLinks” collection this month. There are many examples of medical care gone bad.
October’s newsletter deals with 1) over-diagnosis of mental illness, 2) the secrets of the medical industry, 3) how unintended consequences can occur when physician performance is measured, 4) the death toll on women from painkillers, 5) the need to stop calling so many things cancer, and 6) the issues associated with high blood pressure and too much sodium.”
- Patient Safety America Newsletter (September 2013) Source: Patient Safety America (Wednesday August 28, 2013)
John James’ summary: “Young children often grow up in a world where everything is about their needs, both perceived and real. Wise parents work against this self-centered worldview so that by the time children become adults, they understand that they are not the center of the universe. There is one circumstance where this view must be discouraged – medical care. When receiving medical care you should be the center of all that can be reasonably done for your wellbeing – with you giving informed permission for anything invasive.
In reality, medical care, although headed in the direction of patient-centered care, has a long way to go. My newsletter’s first article demonstrates this reality. The second suggests that intense care is not usually patient-centered for critically ill patients; furthermore, the money we spend on medical care can be misspent, in part due to the fee-for-service scheme that doctors prefer. The third article describes how stress from medical bills can become pervasive, especially for the uninsured.
The fourth article slams the FDA for not enforcing a law that requires drug makers to do additional testing of their drugs, and a fifth criticizes Congress for not requiring stronger control of compounding companies. The newsletter ends with an article on regulating those who could misinterpret images, and with another article on cancer-drug makers who downplay the side effects of their potent products.”
- 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.”