2016 started out with the tragic reminder of how fragile life is. Last week one of my good friends – Karen Langhart took her life. She was just 56 years old.
I will never forget when I first met Karen in 2012 about 6 months after the death of her 24-year old daughter, Erika, from a pulmonary embolism caused by her birth control Nuvaring. We were at a conference in Washington DC and Karen got up in front of the 250+ audience to ask a question of the speaker. She was articulate, smart, poised, and knowledgeable about the subject, and not to mention, quite stunning and tall. I thought she was one of the researchers attending the conference. It wasn’t until she said that she was the mother of Erika who died on the prior Thanksgiving day of Nuvaring. I immediately introduced myself and we became fast friends.
Karen was a mom on a mission to make sure that what happened to her daughter didn’t happen to another family. She worked tirelessly around the clock researching links, causes, and finally setting up a foundation in her daughter’s name – Informed Choice for Amerika.
The Langhart’s story was featured in Vanity Fair and on CNN’s Anderson Cooper. They pursued legal measures against Nuvaring manufacturer Merck. However, in the end they did NOT take the pitiful Merck NuvaRing settlement which would have silenced them for little $. Last month Karen brought together activists, parents, researchers, film makers to Las Vegas for the first Woman Up conference.
Karen was truly a force that couldn’t be reckoned with. A brave soul. She accomplished so much through sheer grit, passion and talent while enduring such deep personal loss.
She will be greatly missed by many.
For me personally, I am still processing her death and how it relates to the bigger picture of advocacy. Karen’s loss is truly significant not only to her husband and son, but to all of us.
Karen did what so many harmed families do. They want to stand up and make difference in a very cumbersome and difficult regulatory, legal and medical system.
Advocating for change after a personal loss takes a lot of energy. You spend countless hours doing everything you can to make sure that no other family has to experience what we went through. Initially, it can be cathartic and help make sense of a tragic and unnecessary death. However, as one discovers the truth about the lies, deception and dangers, it becomes a bigger mission of wanting to make sure others have the information their family didn’t. Knowledge is power.
Advocating for change often feels like a very lonely road going nowhere. From the outside people see you as strong, driven, and effective in delivering your message. However, they often don’t see the inside tears being shed or when you go home to an empty house. Karen’s death is a reminder and makes me give pause to all my fellow advocates who have personally suffered yet are doing something about it. Self care is really important and recognizing when a break is needed. Your voice is the greatest asset for the issue.
Finally, these kind of tragedies don’t just impact the individual person, they affect families, friends and communities forever. Its has a ripple affect. The fall out from medical harm, regardless of cause, can add additional layer of suffering to the event itself. Loss, grief, anger, depression, and the damages to relationships are some of the many issues people experience. These stories of devastation left in the wake of medical harm must also be told and not forgotten.
There are real life consequences to this grueling and often unnoticed advocacy work. We need tireless advocates like Karen who are willing to stand up to corporations, the FDA, the medical establishment to make sure the truth be told. For its the unsuspecting and trusting families, like Karen, Erika, and Woody who pay the ultimate price. Just regular people living their lives until the unthinkable happens.
Karen’s legacy and the work she started will continue to inspire me and others for years to come. Many lives will be saved because of her.
In the words of Margaret Mead, “Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it’s the only thing that ever has.”
RIP my friend. I will miss you more than you will ever know.
In conversations last year with fellow patient safety advocates, we were discussing the story on Vox that makes the point that some hospitals treat medical errors like car crashes and others treat them like plane crashes. It is a catchy piece that makes some good points.
However, as a retired pilot, I have to offer a rebuttal to the notion that health care safety can be made analogous to airplane safety. The cultures are different and the incentives are different.
Pilots sit at the “pointy end” of the aircraft and suffer the same consequences of their errors as do the passengers. They are safety oriented because their lives depend upon safe operations. There are no conflicts of interest for a pilot.
Doctors in the fee for service environment, often including payments by big Pharma and Medical Device companies, have terribly different incentives which prevent safety. Tort reform, confidentiality rules, and bonuses for procedure volume drive their “airplane.” For doctors, there is no consequence for “negative outcomes.”
The proverbial saying that “Pilots die with their mistakes and doctors bury their mistakes” rings very true in our current environment.
In our medical system, there are no consequences for negative outcomes. There are no consequences, as well, for fraud and other criminal acts. The status quo will be difficult to change.
From a legislative perspective, tort reform and confidentiality laws prevent patient safety improvements. Can you imagine if there were tort reform and confidentiality laws legislated to prevent the causes of aircraft accidents from being known or exposed? It is quite ironic that my 40 years of flying came to an end because of medical error involving fraud, confidentiality of findings, tort reform to prevent discovery, lack of credentialing, false credentials, conflict of interest with a medical device corporation, etc.
Can you imagine approval to operate a new aircraft based upon a FDA “510K” process that assumes if you have flown an aircraft before, you can fly any aircraft? In medicine, profit trumps safety.
If aviation operated as our medical system, we would be crashing commercial aircraft each day with no incentive to improve, except, of course being in the pointy end of the plane.
Guest blog post by David Antoon, member of Safe Patient Project activist network and retired pilot]]>
Patients seeking relief from a sinus infection, uncomplicated urinary tract infection, or bronchitis should never become injured or disabled from medications that are supposed to help them.
But that is exactly what happens to millions of people worldwide when they are prescribed a powerful fluoroquinolone antibiotic like Cipro (ciprofloxacin), Levaquin (levofloxacin), or Avelox (moxifloxacin) for routine infections which do not need their strength and for which there are safer alternatives.
Fluoroquinolones are a class of broad spectrum antibiotics that are incredibly powerful with the capability to save lives when used appropriately as a treatment of last resort for life-threatening bacterial infections like anthrax. But these antibiotics also have equal power to destroy lives when they are inappropriately prescribed for routine infections, which don’t need their strength. Prescribing an antibiotic strong enough to treat anthrax for a simple infection is like detonating an atomic bomb to kill a mosquito. Fluoroquinolone antibiotics are associated with severe adverse reactions, which may be permanent and life-threatening.
As the number of prescriptions for fluoroquinolone tablets, IV, eye drops, and ear drops have increased, so have the number of adverse reactions reported to the FDA. These adverse reactions encompass several body systems including the peripheral, autonomic, and central nervous systems, psychiatric, cardiovascular, musculoskeletal system, and more.
The FDA is taking notice of this. The agency has issued a “black box” warning to prescribers of the drug. And in a recent review, the FDA refers to this constellation of symptoms in previously healthy individuals as “fluoroquinolone-associated disability”.
That is exactly what happened to me. I went to my doctor for treatment of a routine sinus infection and instead I was inappropriately prescribed an antibiotic that has disabled me. According to the CDC, up to 50% of all the antibiotics prescribed for people are not needed or are not optimally effective as prescribed.
On November 5, 2015, I was honored to testify at the FDA Joint Meeting of the Antimicrobial Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The panel discussed the risk/benefit ratio of fluoroquinolone antibacterial drugs for the treatment of routine infections. I shared my story of how I was an otherwise healthy individual who was prescribed Levaquin for a routine sinus infection in 2006 and became disabled with ten tendon ruptures, peripheral neuropathy, cardiac problems, and a progressive neurodegenerative disorder from which I will never recover. My sinus infection would have resolved had I been prescribed a safer alternative and I would not have been exposed to the relatively disproportionate risks of known fluoroquinolone-associated injury.
The hearing took place at the FDA White Oak Campus in Silver Spring, Maryland, the same building and conference room as the Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products Hearing on March 27, 2015 at which I testified about how the Pliva v Mensing Supreme Court decision prevents victims harmed by generic fluoroquinolones from pursuing legal action against their makers and how patients are being harmed unnecessarily because generic drug makers are not required to update the safety information on generic drugs.
At the November FDA hearing, 35 people, including me, testified in front of the twenty-one member FDA advisory panel, each sharing their emotional, gut-wrenching stories of how fluoroquinolone antibiotics caused them, or someone they love, irreparable harm. Among them was a woman who lost her son, a man who lost his brother, and dozens of victims who once led healthy, productive lives and can no longer enjoy a reasonable quality of life.
The advisory panel agreed that the risks outweigh the benefits when fluoroquinolone antibiotics are inappropriately prescribed for routine infections and they voted 21-0 for a label revision on sinusitis, 20-1 for UTIs, and 18-2 with one abstention for bronchitis.
Advocating for victims of fluoroquinolone antibiotics, promoting patient safety, educating patients and the medical community, and engaging in research is our primary goal at the Quinolone Vigilance Foundation, and we applaud the FDA advisory panel for taking steps in the right direction to protect patients from preventable harm. By recommending limiting fluoroquinolone antibiotics to life-threatening infections and not prescribing them for routine infections, patients will be protected from life-long injury and disability, and it will help combat antibiotic resistance, a growing world-wide epidemic. These are steps in the right direction because a preventable problem is a fixable problem.
Guest post by Rachel Brummert, Executive Director, Quinolone Vigilance Foundation
Medical harm that has lead to an untimely death of a patient could be traced back to blatant failures of the NIH and FDA to enforce a 2008 law requiring public reporting of required clinical trial results to the federal database clinicaltrials.gov.
A recent article by Charles Pillar, Law Ignored, Patients at Risk alerts us to an alarming violation of a federal law, that requires public reporting of clinical trial results, including some that involve, “…life and death problems.” Even more alarming, the article states our government agencies, the NIH and FDA, are not making sure the law is followed. If FDA had used its fining authority, “In theory, it could have collected $25 billion from drug companies since 2008.”
What can we do when our top government healthcare agencies do not follow, nor enforce, a law designed to provide information that enables timely and safer healthcare? For starters, we can ask the FDA and the NIH to look into this lack of accountability, correct it, and let the public know what corrections have been implemented. Their failure to do this can result in patient harm and death.
Patient advocates across the country are informing others of this failure, and gathering signatures on this letter, which will be sent to all the agencies listed. You can sign on at https://www.facebook.com/events/1666711826933569/1666794830258602/]]>