JustCare

Tag: Patient safety

  • Dr. Oz’s heart valve: A cautionary tale about medical devices

    Dr. Oz’s heart valve: A cautionary tale about medical devices

    Dr. Oz proudly endorses an implantable heart valve that he had a role in inventing, which won FDA approval in 2013. Yet, David Hilzenrath and Holly Hacker report for KFF Health News that the valve might be hurting more people than it’s helping. Overall, the FDA does a poor job of monitoring medical devices on the market and warning people of malfunctions.

    MitraClip, the brand name for the heart valve, is intended to allow patients to avoid open-heart surgery. It could treat tens of thousands of people with mitral regurgitation, a condition in which blood flows backwards through the heart. But, thousands of people have reported that it often doesn’t work and can harm patients. Eleven hundred people have died from the device, according to FDA records.

    The MitraClip is manufactured by Abbott and costs $30,000. As of 2019, it had been inserted in 200,000 people worldwide. And, Dr. Oz has received hundreds of thousands of dollars in royalties from the MitraClip. Yet, one FDA outside adviser said that the data showing clinical benefits of the MitraClip was “poop.”

    In March 2013, the FDA reported to its outside advisors that “approval is not appropriate at this time as major questions of safety and effectiveness, as well as the overall benefit-risk profile for this device, remain unanswered.” In a close vote, the majority of the committee determined that the MitraClip was not effective, but they overwhelmingly thought it was safe and risks were minimal as compared to benefits. And, the FDA approved the device shortly thereafter for a limited group of patients.

    Since its approval, the FDA has recalled MitraClip products three times. One recall warned of “potentially deadly consequences,” but Abbott continued to promote the MitraClip. A pending lawsuit claims that Abbott illegally persuaded doctors and hospitals to use the device. How did the FDA allow this device get to market?

    Bottom line: You should not trust the FDA to protect you from medical devices that are unsafe. The FDA acts extremely slowly and, in some cases, does not act in the interest of Americans. Consequently, thousands of patients are harmed or die needlessly. The FDA and Abbott continue to say that the MitraClip is safe and effective.

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  • New nursing home staffing requirements are a step forward

    New nursing home staffing requirements are a step forward

    It has become increasingly clear that our federal government is not willing or able to enact laws and rules that go as far as necessary to protect consumers. Recently, the Centers for Medicare and Medicaid Services (CMS) issued final rules with regard to nursing home staffing requirements that are a huge step forward and yet not nearly enough, Jordan Rau reports for KFF Health News. Patient safety and adequacy of care remain a concern, even with these rules. 

    Under the new rules, most of the 15,000 nursing homes in the US will have to hire more nurses and aides, beginning in 2026. The nursing homes will, on average, need to offer 3.48 hours of care each day to each resident. Today, some four in ten nursing homes do not do so. But, many advocates do not believe that these rules will ensure that nursing homes deliver high quality care.

    Without a higher ratio of nurses and aides to nursing home residents, it is challenging for nursing homes to care for their patients, as we saw during the Covid epidemic. Instead, residents end up with bedsores, fall needlessly, are not properly diagnosed for their conditions or take more trips to the emergency room.

    At the moment, it’s not clear whether there are enough nurses and aides available for nursing homes to hire. Nursing homes tend to pay less for nurses than hospitals. And, aides can often earn more working in restaurants. If the worker shortage remains, the nursing homes will likely not comply with the new rule.

    CMS projects that its rules will cost nursing homes $6 million more a year. CMS does not plan to increase Medicare and Medicaid payments to cover these additional costs. The nursing home industry calls it an “unfunded mandate” and intends to see if it can persuade Congress (or likely the next Administration) to undo it.

    And, still, CMS is calling for nursing-home staffing levels that are less than excellent, according to the head of the Long Term Care Community Coalition. The rule is a step forward because the previous rule was not specific as to what constituted a “sufficient” staffing level, only that the staffing level be “sufficient.”

    To date, the Office of the Inspector General has found that many nursing homes do not meet many basic staffing requirements.

    Critics of the new CMS rule argue that it will lead to many nursing home closures as nursing homes will not be able to hire more workers. Both the cost of hiring them and the scarcity of workers present obstacles. But, a recent study found that, overall, nursing homes are doing extremely well financially. Owners are able to secure substantial profits through all kinds of shenanigans. A while back, the Kaiser Family Foundation explained how owners profit and advised avoiding chain nursing homes.

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  • How can people protect themselves from unsafe hospitals?

    How can people protect themselves from unsafe hospitals?

    Mary Chris Jaklevic reports for Kaiser Health News on a new patient safety initiative intended to ensure hospitals learn from medical errors. People are calling for a “National Patient Safety Board,” an independent government agency, modeled on the National Transportation Safety Board that helps ensure airline flights are safe. Could such a board improve hospital care and patient safety?

    Hospitals were unable to handle the patient load from the COVID-19 pandemic. Many now are hurting significantly financially and experiencing staffing shortages. The open question is how a new safety board would address these mega issues.

    There’s now an advisory council established by President Biden that is reviewing the merits of a patient safety board that the President would establish by executive order. There’s also a bill in the US House of Representatives,  the National Safety Board Act of 2022, led by Rep. Nanette Diaz Barragan.

    The travesty is that, unlike the National Transportation Safety Board, which can investigate and expose all airline issues, the bill in the House protects hospitals in two ways that threaten patient safety. First, it only allows the safety board to look into issues of patient safety with the permission of hospitals and other health care organizations. Second, the bill prevents the safety board from naming the hospitals it investigates.

    Make no mistake, hospital visits can be dangerous to your health and well-being. More than one in eight hospitalized people with Medicare were unnecessarily harmed in hospital, according to a report by the Office of the Inspector General of the department of health and human services.

    What’s worse is that people do not have the information they need to stay away from hospitals that have serious patient safety issues. Hospitals too often are able to hide their medical errors. They should not be. Moreover, even when hospitals have protections in place, hospitals are often reluctant to report data to national research databases.

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  • Escort requirements keep people from receiving medical procedures

    Escort requirements keep people from receiving medical procedures

    Paula Span reports for the New York Times on outpatient procedures that require patients to have someone to escort them out of the doctor’s office. Consequently, sometimes patients must forego important care because they have no one to escort them out of the doctor’s office afterwards. These escort requirements are a particular challenge for people living alone, without friends and family to assist them.

    There are a range of outpatient procedures for which some physicians require you to have an escort. For example, if you need a colonoscopy or cataract surgery, to name two procedures that require anesthesia, you might not be able to get an appointment if you don’t have an escort to pick you up after the service. Without the name and contact information for your escort, doctors might not allow you to schedule these procedures.

    Easy access to transportation home after a procedure is not enough. Some physicians require people to have someone to get them from the doctor’s office to the taxi or car and then from the taxi or car into their homes. The concern is that the patient might have a bad reaction to the anesthesia and end up in a stupor or vomiting or totally disoriented.

    Not every doctor requires an escort. But, some doctors do. One person enrolled in an Aetna Medicare Advantage plan could not find a doctor to perform a procedure he needed unless he had an escort. But, he did not have one, and Aetna won’t cover the cost of the medical escort.

    An escort requirement is a big issue for many people who live alone and don’t have people to turn to for help. They might need a procedure to stay healthy. But,  if they also need an escort for their safety, they are in a quandary.

    Is there a way to avoid having an escort? If you do not have an escort to accompany you to a procedure where an escort is required, you should ask your health care providers that require escorts whether they would allow you to wait in their offices for several hours after a procedure in lieu of having an escort. Sometimes they will.

    How to get an escort? You might try contacting your local church or religious institution. Or, if you’re up to it, look into volunteering in your community for credits. Organizations like TimeBank allow you to bank credit from your own volunteering to enable you to get a volunteer to escort you home from the doctor.

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  • Why aren’t medical devices tested against placebos?

    Why aren’t medical devices tested against placebos?

    Lizzy Lawrence reports for Stat News on the value of testing medical devices against a placebo. Otherwise, it’s difficult to know whether a medical device offers a benefit. Because the FDA does not require placebo trials, they are rarely performed. And, that suits the device manufacturers just fine.

    For sure, plenty of medical devices on the market are unsafe or of questionable value. They have not been tested thoroughly. And, sometimes, hundreds of thousands of people get them even though they could be harmful. Some experts argue for more device testing against a placebo. The device manufacturers say that a placebo test is challenging, given that a lot of these devices require invasive procedures. But, how many people are getting medical devices that offer no benefit or, worse still, put their health at risk?

    A recent Abbott study to determine whether a device to treat a heart condition was safe and effective compared a cohort of patients using the device, TriClip, with a cohort who simply received diuretics or another medical therapy for heart failure. Both groups had about the same rates of death and hospitalization for heart failure.

    Without a placebo, there’s no way to know whether the device and the intervention work. The device makers don’t want to incur the expense of a placebo trial, and claim it is hard to find patients to participate. The FDA has not required placebo testing.

    Rather, the FDA has allowed countless “low-to-medium risk” medical devices into the market based on nothing other than their “substantial equivalence” to a device already on the market. And, the FDA takes a liberal view of the meaning of  “substantial equivalence.”  It also does not appear to factor in the safety and efficacy of the device already on the market.

    The FDA requires only “high-risk” medical devices to be shown to be safe and effective before approving them for use. Only one in 20 medical devices are classified as “high-risk.” And, most of these devices are not tested against a placebo for safety and efficacy.

    Of course, placebo testing has risks as do medical devices that offer no benefit. Moreover, placebos are not always even possible, such as in the case of bypass surgery. What to do to ensure medical devices are safe and effective?

    Interestingly, if patients think that they might have gotten a placebo, they are less likely to respond as well to it. To do a meaningful placebo test, it appears that patients need to hear enough about the procedure that they believe it really happened. They need to be told about all the steps taken; the fewer the steps, the less likely the patient will believe the treatment is for real.

    Here’s more from Just Care:

  • Non-profit hospital systems compromise patient safety

    Non-profit hospital systems compromise patient safety

    The New York Times reports on how Ascension, a non-profit hospital chain operating in 16 states and serving millions of patients a year, created its own staffing crisis while building an $18 billion reserve and paying its CEO $13 million in 2021. The for-profit hospital chains are behaving no better and could be worse. What’s going on?

    Most hospitals in the US are non-profit. They don’t pay taxes. In exchange, they are supposed to offer charity care and community assistance. But, many are not providing the charitable services expected of them. Staffing is inadequate, often at the poorest hospitals, and charity care is hard to come by.

    Ascension operates 139 hospitals. It has been cutting its staff for several years now. Even though it’s a non-profit hospital system, its executives worked to improve its “profits.” Consequently, patients at some of its hospitals have needed to wait a day just for a hospital bed, and the ratio of patients to aides at one of its hospitals was 32 to one!

    Ascension executives used to boast about its staff-cutting, reducing labor costs by $500 million. Despite thousands of complaints from nurses about understaffing, executives refused to hire more staff. Sometimes, nurses were not available to clean or turn patients who were bed-bound or to treat their open wounds.

    When the pandemic hit, Ascension was unprepared. It could not take all the patients that needed care. More than a thousand nurse positions were vacant. Emergency rooms were not equipped.

    Ascension is not alone among non-profit hospital systems in its desire to limit labor costs in an extreme way. It is one among many non-profit hospital systems that have turned their backs on patient care. The New York Times reports that Providence hospital system also cut staffing significantly, as has CommonSpirit Health, forcing patients to wait extended periods to get needed care.

    The New York Times investigation focused on two Ascension hospitals that nurses reported put patient safety at risk. Nurses complained formally day after day to no avail. Independent health inspectors cited Ascension for failing to care for patients with bed sores appropriately. At the same time, Ascension’s former CEO was earning $11 million a year to run Ascension’s investment division.

    To keep costs down, Ascension executives gave CEOs at its hospitals financial goals. If they could not meet them, they would not receive bonuses. At the same time, Ascension tried to keep Illinois and Michigan legislators from setting nursing to patient ratios at hospitals. Needless to say, staffing levels at Ascension hospitals were often inadequate to meet patient needs; surgeries needed to be delayed and ambulances could not bring patients to the Ascension hospitals because there was not enough staff to treat them.

    Ascension went so far as to replace staff at dozens of its hospitals with 450 “telesitters,” robots with video cameras monitored off-site. Off-site staff speak to patients through the telesitters. To make up for inadequate staffing levels, Ascension often expected nurses to work 16 hour shifts and care for more patients than permissible under their contracts.

    No one knows how many patients are dying needlessly as a result of Ascension’s cost-cutting and inadequate staffing levels. Why would Ascension keep track? Are Ascension’s executives looking to sell out to a private equity firm? My bet is that the executives are planning for Ascension to convert to for-profit status and expecting a whopping payout.

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  • FDA hides information on deadly heart pump and threatens patient safety

    FDA hides information on deadly heart pump and threatens patient safety

    Neil Bedi reports for ProPublica on the FDA’s failure to protect patient safety in allowing a sometimes deadly heart pump to remain on the market and a new congressional investigation of the FDA. The FDA has let a number of unsafe products remain on the market after being made aware of grave patient safety issues with them, hiding information from the public. Never allow any device to be implanted in your body or the body of someone you love without first learning how long it has been on the market and your options.

    The HeartWare Ventricular Assist Device, HVAD, which is intended to help people with severe heart failure has not met federal standards since 2014. Because the FDA did not act to take it off the market, thousands more people received the device.

    At least 3,000 people with the device are known to have died because of it. In some cases, its pump was faulty. In others, it simply would stop working. Finally, in June 2021, Medtronic stopped marketing it.

    Why didn’t the FDA intervene if it truly believes that patient safety is its “highest priority?” Why didn’t it notify doctors, patients and other federal agencies about the safety issues with the device? Medtronic claims that 90 percent of patients now know it was discontinued.

    Around 2,000 people still have this HeartWare pump. And, they are likely stuck with it because it is extremely risky to remove it. It requires surgery.

    While you might not be able to find evidence on malfunctions with medical devices, it’s a good rule of thumb to ensure a device has been in use for at least a decade. Usually, serious problems come to light by then. You should also talk to your doctor about known side effects.

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  • Federal government cannot ensure hospital safety or quality during a pandemic

    Federal government cannot ensure hospital safety or quality during a pandemic

    If you think that it’s the federal government’s responsibility to ensure patient safety and quality in hospitals, Medicare for all would help. Right now, private accreditation agencies and states are charged with overseeing hospitals on many safety issues. And, states tend to lack the skill, the will and the resources to conduct needed oversight, while accreditation agencies can be conflicted or unavailable. Consequently, in our current system, as Health Care Dive reports, we are at risk of being ill-prepared for the next pandemic.

    The HHS Office of the Inspector General just issued a report explaining the health care safety dilemma we face as a result of our multi-payer health care system. It recommends regulatory changes that would give the Centers for Medicare and Medicaid Services authority over accreditation organizations in public emergencies and to control the spread of infectious diseases.  While this is theoretically possible without Medicare for all, it’s hard to see how this fix would be enough in our fragmented healthcare system.

    The federal government has no access to real-time hospital data, except for traditional Medicare patients. That’s not enough to see where problems lie at hospitals and to address them. And, CMS cannot require hospitals or accreditation agencies to perform targeted infection control surveys.

    The federal government should be able to require hospitals to undergo additional surveys during public health emergencies because they all contract with the federal government to treat Medicare and Medicaid patients, Right now, surveys generally take place every three years.

    The federal government should have more authority over hospitals and hospital-accrediting agencies. Without that authority, it cannot ensure quality and safety. Accreditors sometimes have conflicts of interest with the hospitals they are accrediting. Four years ago, the Wall Street Journal reported on hospitals that were fully accredited even though they were seriously out of compliance with safety requirements.

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  • Need a life-saving drug you can’t afford? Consider importing it.

    Need a life-saving drug you can’t afford? Consider importing it.

    Do you or someone you love need a life-saving drug that your insurer won’t cover or you can’t afford? Consider importing it. Outside the U.S., prescription drug costs are far lower than in the U.S.

    Sophie Cousins writes in The New York Times about one 60- year old Tasmanian man with hepatitis C, Greg Jefferys, who wanted the 12-week oral hepatitis C drug called sofosbuvir or Sovaldi, which the Australian authorities had not yet approved. However, it was available in the U.S. for $84,000 and in India for under $1,000. So, he identified a doctor and a licensed pharmaceutical supplier, flew to India, and got the treatment he needed to kill his virus.

    Importing drugs for personal use is legal in Australia, and no one in the U.S. has ever been prosecuted for so doing. Jefferys ended up starting a small business to help people get the hepatitis C vaccine shipped to them in their home countries. He set up buyers’ clubs in different countries to make it as easy as possible for people who needed the vaccine to get it.

    If you need the vaccine or any other costly drug and don’t want to travel to get it, you can often get it shipped to you for personal use. Bull Pharmachem in Mumbai is a licensed wholesale distribution house, shipping hepatitis C drugs, as well as drugs for hepatitis B, cancer and H.I.V. You can get the hepatitis C drug in 10 days from India.

    While you always need to be careful about the source of the drugs you’re buying online, there are no reported patient safety issues if you buy drugs from reputable licensed pharmacies. If you are careful, you should have the same treatment outcomes whether you buy the drug online or not according to a recent study in Australia.

    Importing drugs for personal use is not a wholesale solution to the astronomical prices Congress allows pharmaceutical companies to charge for drugs. But, millions of Americans have no choice but to do it. The House of Representatives has passed a bill that would bring down the cost of scores of drugs to about the same price as other wealthy countries pay. But, the Republican-led Senate is not prepared to take it up. So, for now, importation is often the only option. 

    If you want Congress to rein in drug prices, please sign this petition.

    This post was originally published on August 2, 2017 and updated.

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  • Do new cancer treatments offer meaningful benefits?

    Do new cancer treatments offer meaningful benefits?

    Stat News reports on a new study, published in BMJ, which finds that around 50 percent of the clinical trials for cancer treatments approved in Europe may not demonstrate meaningful benefits. Risk of bias in the design and reporting of clinical trials may mean that the drugs lack both therapeutic and financial value. Studies of clinical trials for cancer drugs approved in the US have similar flaws.

    For the BMJ study, researchers looked at the strength of the evidence supporting new cancer drug approvals in Europe. They analyzed 54 clinical trials for the 32 cancer drugs approved between 2014 and 2016. Of those with published studies, only one in four looked at overall survival rates. All the other trials, 29 out of 39, used “surrogate measures.” Surrogate measures cannot predict whether someone will live longer or enjoy a better quality of life. Some academics say they may undermine patient safety.

    Researchers found that just about half (49 percent) of the published trials had a high risk of bias. They found a much higher risk of bias in the trials looking at surrogate measures of patient benefit (55 percent) than in the trials measuring overall survival (20 percent). Note: Researchers found risk of bias, not actual bias.

    Only 75 percent of the drug studies (41 of them) from 2014 to 2016 involved randomized, controlled trials. Just 27 of the 32 newly approved cancer drugs had a randomized trial. Between, 2009 and 2013, 90 percent of the studies involved randomized, controlled trials.

    In addition, of the 32 drugs approved, 10 had problems identified by regulators. But, somehow, the regulators’ concerns about these drugs did not make it into the scientific literature.

    The researchers recommend that clinical research for drugs be based on randomized trials and that these trials study data on meaningful outcomes, specifically overall survival. Without this research, it is hard to know whether new cancer drugs meet patients’ needs. It’s best to have a quality assessment of the evidence as well. Bias in clinical trial design is a serious issue.

    The researchers also want more transparency from regulators. Patients should know the weaknesses of the research underlying a new drug and how these weaknesses might affect the trial results.

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