The FDA Owes Patients Improved Medical Device Regulation After Dr. Amy Reed's Death

The FDA Owes Patients Improved Medical Device Regulation After Dr. Amy Reed's Death

Kirsten Clodfelter  JUN 30, 2017 @ 07:05 AM   FiDA highlight

Dr. Amy Reed, an anesthesiologist and patient-safety advocate, died in May 2017 after a four-year battle with leiomyosarcoma of the uterus. The cancer was spread by a power morcellator, the medical device used for her 2013 hysterectomy.

The surgical tool, released in 1995, was once lauded for facilitating minimally invasive surgery that decreased recovery times and minimized the risk of post-surgical infections. Morcellation, used to remove uterine fibroids or conduct complete hysterectomies, was performed on approximately 50,000 women a year in the U.S. in the early 2010s.

Yet for patients like Dr. Reed, whose uterine fibroids appeared benign but hid an aggressive type of cancer, morcellation can become a death sentence. The device is equipped with a spinning blade, which slices up tissue for removal piece by piece through small incisions. When the blade cuts through a cancerous tumor, it sprays malignant cells around the body, spreading the disease. Following her procedure, Dr. Reed, a mother of six, was left with advanced, Stage 4 cancer.

to be continued on Forbes website:  https://www.forbes.com/sites/kirstenclodfelter/2017/06/30/the-fda-owes-patients-improved-medical-device-regulation-after-dr-amy-reeds-death/#400df9afdc90

Forbes: FDA Approval MEANINGLESS!

The FDA Is Basically Approving Everything. Here's The Data To Prove It

Matthew Herper  AUG 20, 2015 @ 5:53 AM 

Remember when the FDA rejected drugs?

We just got treated to a whole lot of drama this week as to whether Addyi, a drug to boost women’s libidos, would be approved. But based on the data, that approval was probably a foregone conclusion.

As recently as 2008, companies filing applications to sell never-before-marketed drugs, which are referred to by the FDA as “new molecular entities,” faced rejection 66% of the time. Yet so far this year the FDA has rejected only three uses for new chemical entities, and approved 25, an approval rate of 89%.

Those numbers come from a new analysis commissioned by Forbes from BioMedTracker, a division of publishing giant Informa that helps investors track events in the pharmaceutical industry. And if you dig into them, the drop is even sharper.

The way BioMedTracker follows new molecular entities is slightly different from the FDA does. BioMedTracker users want to know about every use of a new medicine. That means that the 2015 rejection count includes rejections of Avycaz, a new antibiotic from Allergan ngIf: ticker AGN -1.27% ngIf: show_card end ngIf: ticker , for hospital-acquired pneumonia, and selling Jardiance, a diabetes drug from Eli Lilly ngIf: ticker and Boehringer Ingelheim ngIf: ticker , in combination of metformin. But Avycaz was approved for two other uses and Jardiance is on the market by itself.

So in reality, the FDA approval rate is more like 96%. Eliminating BioMedTrackers counting of multiple uses for the same drug means FDA approved 23 drugs and rejected 1, Merck ngIf: ticker ’s anesthesia antidote, Bridion. Again, that means 19 of 20 new drug applications were approved.

But it’s worth sticking to BioMedTracker’s definitions, because it allows us to compare this incredibly high approval rate with the past. And that tells a story of an agency that has been giving the green light more and more often.

In 2008, BioMedTracker says the FDA approved 20 new molecular entities (NMEs) and rejected 20, for an approval rate of 50%. In 2009, the NME approval rate fell to 44%, as 28 uses were rejected and 22 were approved. That rate rose to 86% in 2011, partly as some of those rejected drugs reached the market, fell again to 60% in 2013, and in last year rose to 88%. The evidence is that we’re living in a golden age of drug approvals, at least from a drug company’s perspective.

And there’s even more data to back up the contention that the FDA is basically providing a rubber stamp. BioMedTracker doesn’t just track what happens to NMEs, or new drugs. It follows closely every time a company asks the FDA for an approval. (One flaw in the data: while drug approvals are a matter of public record, we only know about rejections, known by the euphemism of “complete response letters,” if drugmakers feel the need to share them publicly.

For this analysis, BioMedTracker also looked at every time that a company asked the FDA to either approve a new drug or approve a new marketing claim for an existing medicine. The numbers parallel what was seen with brand new medicines.

In 2008, companies asked for 134 approvals and got 75 of them, a 56% approval rate. That rate hovered steady in 2009 and 2010, and then rose to about 70% in 2011, 2012, and 2013. Last year it jumped to 77%, with 97 out of 126 requests for approval coming back positive. This year’s approval rate? It was 88%.

Again, nine out of ten times, when a pharmaceutical company asks the FDA for a new marketing claim, it gets it. That’s why all of the arguments about Addyi, whose maker, Sprout Pharmaceuticals, is now being bought by specialty pharma giant Valeant Pharmaceuticals ngIf: ticker for $1 billion, were a little silly. The odds of a rejection were low at best.

The FDA points out that one reason that drug approval rates are going up is because it is doing its job, as defined by Congress. The agency has deadlines for when it is supposed to approve new drugs, and it is meeting them. More than that, it has instituted new procedures to make sure it communicates well with drug companies before they file new drug applications. And the FDA has had a program to ask patient advocates what they want. Many sick patients would prefer that the FDA approve a drug with a marginal benefit than reject it.

Right now, it only looks like this trend will continue. A new bill called the 21^st Century Cures Act attempts to further speed up approvals and remove red tape.

But the risks of speeding up approvals should be pretty clear, too. In the late 1990s and early 2000s, there was a boom of new drug approvals. In 1999, the FDA approved two drugs that became synonymous with drug safety scandals: Vioxx, which was withdrawn from the market by Merck, and Avandia, made by GlaxoSmithKline, which later had its use severely restricted. The approval boom is good only so long as it doesn’t trigger another drug safety conference.

That’s why we should tread carefully here. Already, the FDA is approving drugs almost all the time. It is doing so rapidly, with appropriately lower standards for rare diseases. How low do we want the bar to go?

And it seems appropriate to also give a warning to biotechnology investors. For any drug facing an FDA decision in the near term, this is good news. Worried about whether the muscular dystrophy drugs being developed by Sarepta and Biomarin will be approved? The odds are probably better than you think.

But we’re also living through an unprecedented biotech boom, with the iShares Nasdaq Biotechnology Index up 360% over five years in part because the regulatory environment for drug companies has improved. Well, this could be as good as it gets. If 96% of new drugs are getting approved, approval rates can only go down. If you’re looking for an indication that we’re hitting a peak, this could be it.

And I think it’s likely that the current approval rates are as much a result of the political environment as anything else. To the extent that they think about the FDA, politicians on the right generally want the FDA to get drugs to patients faster, giving them choices. Those on the left worry more about approving dangerous drugs.

But the FDA doesn’t follow the tone set by the President or the party in power, because the FDA is never the center of anybody’s agenda. Instead, its tendency, even if its unconscious, is to protect itself against attacks from the opposing party. A lame duck Democrat and a Republican Congress? You’re going to get an easy FDA. If a Republican wins the White House next year, think about selling your drug stocks.

I posted the article on my Facebook page with this comment:  

Thank you, Helen Haskell for sharing this article. I was trained 9/2010 at FDA/CDRH to be a Patient Representative. I have NEVER been contacted to serve on an AdvisoryPanel. Patient Representatives are NON-VOTING and most devices are cleared as 'substantially equivalent' 510(k)-grandfathered. I would like to see a similar report on medical devices and have a requirement that this information be a part of 'Informed Consent' for the patient.

The Truth About Big Medicine - Dallas book launch Monday, January 19, 2015

The book is available from the publisher Rowman & Littlefield both electronic version or hardcover.  https://rowman.comISBN/9781442231603 promotion code 4F14BROJA (30% discount valid until December 15, 2015-not to be combined with any other offer)
Meet the author
John T. James, PhD, is the former chief toxicologist at NASA/Houston where he received numerous meritorious awards and wrote many book chapters and monographs dealing with spaceflight safety. As a result of the loss of his oldest son to medical errors in 2002, he has become a patient safety activist, having published a book in 2007 about his son’s care (A Sea of Broken Hearts) and proposing a national patient bill of rights to empower and protect patients.

He publishes a monthly electronic newsletter on patient safety issues and has been appointed to the State of Texas Healthcare Acquired Infection and Preventable Adverse Event Advisory Panel. He just published an evidence-based, peer-reviewed study in a medical journal in which he estimated that more than 400,000 Americans have their lives shortened by medical errors in hospitals. He founded Patient Safety America, whose website is http://PatientSafetyAmerica.com.

http://www.forbes.com/sites/michaelmillenson/2015/01/18/safe-doctors-unsafe-patients-a-tale-of-two-infections/

PHARMA & HEALTHCARE 1/18/2015 @ 12:21PM 776 views

Safe Doctors, Unsafe Patients: A Tale of Two Infections

Michael Millenson

Call it a tale of two infections. It’s the story of how hospitals have blocked transmission of a dangerous infection that patients can give doctors, while a hospital-caused infection that can kill patients continues to be widely tolerated. It involves saved lives and endangered ones ­– and also of billions of dollars spent needlessly due to unsafe care.

The infection that’s been conquered is occupational transmission to doctors and other health care workers of HIV, the virus that causes AIDS. When AIDS first burst on the scene in the early 1980s, it was “disfiguring, debilitating, stigmatizing and inevitably fatal,” in the words of Dr. Paul Volberding, a treatment pioneer. With the disease’s spread poorly understood, “the fear of contagion [was] hanging over our heads,” Volberding recalled.

However, once the mode of transmission was identified– exposure to HIV-infected blood or other bodily fluids – precautions were rapidly put into place. From 1985 through 2013, there were just 58 confirmed cases of occupationally acquired HIV infection reported to the Centers for Disease Control and Prevention (CDC), according to a Jan. 9 CDC report. Since 1999, there’s been only one confirmed case of occupational transmission, involving a lab tech infected via a needle puncture in 2008.

Reported occupational infection “has become rare,” the CDC concluded, likely due to prevention strategies and “improved technologies and training.”

At the same time hospitals were eliminating the danger of patients infecting health care workers with HIV, most were doing little to stop the dangerous infections hospitals can give patients. In 1999, the Institute of Medicine (IOM) issued a landmark report declaring that 44,000 to 98,000 patients died each year from infections and other preventable medical errors in hospitals. This “epidemic,” as the IOM put it, killed more Americans than breast cancer or AIDS. (Later research put the preventable deaths at from 210,000 to more than 400,000 annually.)

Yet by 2008, the same year as the last reported occupational exposure to HIV, studies would show that most hospitals had done very little to prevent patient harm. That year, however, the Agency for Healthcare Research and Quality launched an ambitious effort to fight one particularly expensive and dangerous infection that, like HIV, was extensively studied. It’s called a central-line associated bloodstream infection, or CLABSI.

Bloodstream infections from catheters placed deep into a sick patient’s torso have a higher mortality rate than typhoid fever or malaria. They’re also the most costly of healthcare-associated infections, costing an average $46,000 per patient. The good news was that a five-step “checklist” approach, including such simple items as hand-washing and cleaning the patient’s skin with a disinfectant, was startlingly effective at CLABSI prevention. A study of checklist use in the New England Journal of Medicine documented how a large group of hospitalsreduced CLABSIs by nearly 70 percent in just 18 months. During that brief time, they saved more than 1,500 lives and nearly $200 million, researchers estimated. Many of the hospitals eliminated CLABSIs altogether.

So did hospitals everywhere rush to conquer CLABSIs the way they’d triumphed over occupational HIV transmission? Not quite. The latest CDC report, also issued in early January, shows that during the five-year period from 2008 to 2013 CLABSIS declined only 46 percent. What happened?

As I’ve previously written, the CDC calls CLABSI elimination a “winnable” battle but refuses to set zero CLABSIs as a formal goal. Yet despite that leniency, hospital data I obtained from the Medicare program show that in fiscal 2013, 1,197 hospitals ­– 42 percent of acute-care hospitals treating adults and reporting to the CDC – had zero CLABSIs in their intensive care units.

Indeed, though the CDC concedes in its latest report that “specific steps to prevent” CLABSIs could reduce them “by more than 70 percent” from a baseline rate, its own goal for Sept. 30, 2015 is just a 60 percent reduction in the base rate. Given the progress by hospitals so far, that’s unlikely to be met.

So this is the human cost of this tale of two infections: when it comes to doctors, nurses and other workers being endangered by the patient-transmitted HIV virus, hospitals have been extraordinarily safe: in a nearly 30-year period, just 24 nurses and not one physician suffered a confirmed infection. (Similarly, the recent Ebola threat has mobilized the CDC and hospitals.) By comparison, 1,300 patients died preventable deaths from hospital-caused CLABSIs in fiscal 2012 alone, according to research in the American Journal of Medical Quality. Many more suffered infection but recovered.

As for the financial impact, the medical costs of treating health care workers infected by needlesticks for all types of bloodborne pathogens (such as HIV and hepatitis) amounted to $107 million in 2004, the latest research available. Estimates of the medical costs of CLABSIs vary, but $2 billion in 2012 dollars is a conservative one.

While there are valid reasons CLABSI prevention can sometimes fall short, the power of the exact kind of procedures that halted occupational HIV has been repeatedly demonstrated. As recently as last fall’s meeting of the Infectious Disease Society of America, one hospital said it prevented CLABSIs by improving hand hygiene. Another credited success to boosting compliance with a “bundle” of CDC recommendations to 85 percent from 66 percent.

Just one question remains: if doctors, nurses and hospital staff were the ones being harmed, would today’s rate of deaths and injuries from CLABSIs constitute a crisis for the CDC or anyone else?

http://www.forbes.com/sites/neilversel/2014/12/24/feds-private-sector-finally-get-serious-about-medical-errors/

 12/24/2014 @ 9:16AM 

Feds, Private Sector Finally Get Serious About Medical Errors

Neil Versel Contributor

I cover health IT, healthcare quality and patient safety

Hit them where it hurts. Shame them. Do whatever it takes to bring attention to the epidemic of medical errors in American hospitals. That’s exactly what the federal government and several private entities have done this month, hopefully to great effect.

There are at least 210,000 preventable deaths each year in U.S. hospitals attributable to adverse events, according to a study by not-for-profit Patient Safety America(John T. James), published in the September 2013 edition of the Journal of Patient Safety.The number could be as high as 400,000, the same study suggested.

Last week, the federal Medicare program brought down the strongest hammer it has wielded to date, cutting payments to 721 hospitals nationwide, including some big names like the Cleveland Clinic, the Harvard-affiliated Brigham and Women’s Hospital in Boston, Intermountain Medical Center in Salt Lake City and Ronald Reagan UCLA Medical Center in Los Angeles. The 1 percent fee reductions will cost those 721 facilities a total of $373 million. 

Those penalized are among the top 25 percent in hospital-acquired conditions, as called for by the Patient Protection and Affordable Care Act — you know, Obamacare. Yes, the ACA is about a whole lot more than just insurance coverage and online marketplaces. There is real healthcare reform in there, but you wouldn’t know that if you just watched TV news, listened to radio bloviators and read partisan blogs.

Since 2012, also courtesy of the ACA, Medicare has been refusing to pay hospitals for patients readmitted within 30 days of initial discharge for several conditions, including heart attack, pneumonia and congestive heart failure.

These measures aren’t just meant to be punitive; they are supposed to shift incentives so hospitals have a financial reason to provide adequate follow-up care, reduce errors and prevent infections. No longer do hospitals make more money by being sloppy and keeping patients sick. And no longer can prestigious institutions skate by on their reputations alone.

Meanwhile, 40 states and the District of Columbia received failing grades this month from the Health Care Incentives Improvement Institute, a Connecticut-based organization run by François de Brantes, former leader of healthcare improvement initiatives for General Electric. Those states flunked for their inability to provide clear, objective, publicly available information on physician quality. Another four states earned D grades, while only Minnesota scored an A.

“How any legislator or public official, whose very job and oath is to protect the citizens of their state, can willingly accept the lack of information on the quality of physicians is puzzling and sad,” the group’s report bluntly says.

I couldn’t agree more. It’s time to be blunt, either with words or, preferably, money. Too many people die unnecessarily in U.S. hospitals, and millions more are harmed by poor processes and lack of accountability.

http://ctmirror.org/op-ed-ct-hospitals-must-do-more-to-prevent-errors-and-patient-harm/

Op-Ed: CT hospitals must do more to prevent errors and patient harm

By: LISA FREEMAN | January 14, 2015

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So much for safety huddles!

The Connecticut Hospital Association and Connecticut hospitals have been loudly praising their own efforts to improve patient safety and outcomes in our state’s hospitals.  They talk about working with reliability experts to address system flaws that are harming patients. But they can’t talk proudly of the results of that work when a recent national report on infections placed Connecticut 50th of 50 states and a Department of Public Health report recently released shows a dramatic increase in safety failures in our hospitals.

Thank heaven for public reporting.  Due to the efforts of the CT Center for Patient Safety, AARP, and then-Attorney General Richard Blumenthal,  Connecticut has passed two bills requiring hospital-specific infection and adverse event reporting.  Unlike other states, our hospital association has historically owned and controlled the data that provides a window to what is going on.

The two reports that have recently become available should make us all focus on demanding that every hospital CEO stand up in public and say he or she will make patients the focus and safety a solemn top commitment.  Why are so many of them being paid over a million dollars each year when a person who is harmed might actually face bankruptcy because of an error on their watch?

Where are the CEOs on this issue? What has happened to the hospital boards of directors?  Why aren’t your boards demanding responsibility and accountability for fulfilling the hospital mission?

Moreover, our Department of Public Health needs to put some real teeth into whatever it is DPH is doing. DPH comments on their disappointing recent report seem much too complacent when a sense of urgency is called for. As unwelcome as it may seem, the regulatory relationship with hospitals should be adversarial if that is what it is going to take to help the public receive safer care.

Hope is not a method.  Action and accountability are required -- and required now.  For every patient getting an infection today, or finding that the doctor performed surgery on the wrong site, or discovering extra surgery is needed because an object was left in -- just a few of the most egregious errors -- that person cannot wait for the next safety huddle.

The hypocrisy of these institutions is galling.  We are told to trust – but sorry, that trust has been broken.

The Journal of Patient Safety reported last year that between 200,000 and 400,000 deaths each year can be attributed to medical error.  This is a national emergency - and Connecticut is having its own.

Errors are preventable – it’s time to prevent them. For the full report on just how badly we are doing in Connecticut go to this Medicare site, this story by the Connecticut Health Investigative Team,  and this Connecticut Department of Health report to the General Assembly.

Lisa Freeman is executive director of the Connecticut Center for Patient Safety