JustCare

Tag: FDA

  • 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.

    Here’s more from Just Care:

  • Low-cost hearing aids should be available over the counter in 2022

    Low-cost hearing aids should be available over the counter in 2022

    Tens of millions of Americans, mostly older Americans, would benefit from hearing aids. If the Senate passes the Build Back Better Act, which the House has already passed, Medicare would  cover hearing aids under Part B. People with severe hearing loss tend to need expensive hearing aids, but Julie Jargon reports for the Wall Street Journal on low-cost hearing aids for people with mild to moderate hearing loss, which should be available over the counter in 2022.

    What’s happening? The Food and Drug Administration (FDA) is in the last phase of approving the sale of hearing aids without the need for a medical exam or a visit to the audiologist. These hearing aids for people with mild to moderate hearing loss should cost no more than a few hundred dollars. That’s far less than the cost of hearing aids fitted by audiologists, which can easily be a few thousand dollars.

    How many people need hearing aids? Today, nearly 40 million Americans have hearing loss. But, only about 20 percent of people who need hearing aids for good hearing have hearing aids. They are too expensive, and there is a stigma to wearing them.

    How important is it to address hearing loss? Hearing aids bring significant benefits, even for people with mild to moderate hearing loss. Without a hearing aid, it can be hard to engage in social activities, leaving people prone to social isolation. For your health and well-being, it’s important to be socially engaged.

    Some experts believe that you need to be socially engaged in order to keep your mind sharp. One study of 600 adults over 12 years found that even people with mild hearing loss are twice as likely to develop dementia if they don’t use a hearing aid. People with moderate hearing loss are three times as likely to develop dementia if they don’t use a hearing aid. People with severe hearing loss quintuple their risk of getting dementia.

    What are your options today? Right now, many people only have the option of spending $5,000 on hearing aids, which is not a viable option at all. Until you can buy over-the counter hearing aids, consider getting a hearing test if you are struggling to hear. You can take a test through a free phone app, like Mimi. The test might help you know whether you will benefit from an over-the-counter hearing aid or whether you need to see an audiologist.

    How to choose an over-the-counter hearing aid? Several types should be available next year. Some will work in conjunction with your mobile phone, others will be simpler. Whichever you go for, make sure you can return it if it does not meet your needs.

    Hearing assistance is already available. Some hearing buds and apps amplify sounds or cancel out background noise. Some apps provide captions on your TV. Check out this link for a list of different apps available for free.

    And, if you’re not sure whether your hearing is as good as it could be, consider asking your friends whether they think your hearing would benefit from a hearing aid.

    Here’s more from Just Care:

  • New Alzheimer’s drug drives up Part B premiums

    New Alzheimer’s drug drives up Part B premiums

    As with all health care costs, Medicare out-of-pocket costs are rising rapidly. In 2022, Medicare Part B premiums, which everyone with Medicare must pay–except for people with Medicaid–will be 14.5 percent higher. The reason in large part is Aduhelm, the new Alzheimer’s drug, which Medicare is likely to begin covering under Part B and which costs a hefty $56,000 a year.

    About half of the Medicare Part B increase–$15 a month or $180 a year–can be attributed to an expected Centers for Medicare and Medicaid Services’ final determination that Medicare should cover 80 percent of the cost of Aduhelm. It is unacceptably tragic that Medicare would cover this extraordinarily costly drug, which has yet to show any benefits in clinical trials, yet does not cover long-term nursing home care and home care, or vision, hearing and dental care, which we know would benefit everyone.

    Part B premiums for almost everyone with Medicare will be $170.10 a month in 2022, up $21.60 from this year. For people with annual incomes over $91,000, these premiums will be even larger. While Social Security benefits are increasing an average of $90 a month, this Medicare Part B premium increase will eat into more than 20 percent of that benefit increase.

    Right now, few insurers are willing to pay for Aduhelm. And, for good reason. There is no evidence that it slows the progression of dementia and provides benefits worth anything close to its $56,000 a year price tag. But, it has been approved by the Food and Drug Administration. And, the Centers for Medicare and Medicaid Services historically has covered all drugs that are FDA approved, though it is not obligated to do so.

    The non-profit Institute for Clinical and Economic Review has ascribed a value of around $5,000 a year to Aduhelm, based on the little known about its benefits. That’s about ten percent of what Biogen, its manufacturer, is charging for it.

    Nothing in the Build Back Better legislation currently being finalized in Congress would bring down the price of Aduhelm. At best, the bill would bring down the cost of 60 drugs that Medicare covers, beginning with the 10 that are the most expensive for the program, so long as they have been on the market for nine years or more and 12 years or more for biologics.

    If approved, Aduhelm will be covered under Medicare Part B, because it must be administered by a physician and cannot be bought at the pharmacy. In addition to bearing the expense of higher Part B premiums, people in traditional Medicare will likely see significantly higher premiums for supplemental insurance. And, people in Medicare Advantage plans will likely see far higher out-of-pocket costs.

    Here’s more from Just Care:

  • Coronavirus: Should you get the Pfizer booster vaccine?

    Coronavirus: Should you get the Pfizer booster vaccine?

    The FDA gave emergency approval to Pfizer’s “booster” vaccine for people over 65 who have been fully vaccinated against Covid-19 at least six months. And, soon after, the Centers for Disease Control and Prevention (CDC)  announced that it supports that decision as well as booster shots for people who have a serious medical condition or work in a high-risk settings.

    In short, about 60 million of the 100 million people who received the Pfizer vaccine and who are at high risk of getting a serious case of Covid-19 are eligible for the booster shot.  The booster is the same Pfizer vaccine as people originally received, just a third one, to boost people’s antibody levels and better protect them.

    Older adults and people with compromised health need vaccine protection. Covid-19 is the deadliest disease in American history, deadlier than the Spanish flu of 1918.

    Pfizer had wanted the booster to be available to all 100 million Americans who had received its vaccine. But, an expert FDA panel did not support Pfizer’s request, nor did the Centers for Disease Control and Prevention. Still, projections are that booster shots around the world will contribute $26 billion to its bottom line in 2022, PBS reports.

    Should you get a booster if you did not get the Pfizer vaccine? The FDA has not yet given approval for a booster to people who had the Moderna and Johnson & Johnson vaccines. For that reason, experts have not  recommended a Pfizer booster to people who received the Johnson & Johnson or Moderna vaccines.

    Some experts believe that people who are immunocompromised should get the third vaccine even if it is a different brand from the brand they initially received. But, one FDA representative says there is not enough evidence to know whether it would be as effective as getting a third injection of the same vaccine you originally received.

    Here’s more from Just Care:

  • Our drug supply needs an overhaul

    Our drug supply needs an overhaul

    Farah Stockman writes an opinion piece for The New York Times on our “sick” drug supply and why it needs an overhaul. The piece is chilling because it highlights the lack of quality monitoring in the production of prescription drugs. And, of course, pharmaceutical companies’ incentive to cut corners in the production and distribution process.

    Stockman explains that the US used to manufacture many more drugs at home and had significant quality control over the ingredients in our drugs. Today, American manufacturing plants are closing down. Pharmaceutical companies are relying on factories abroad to manufacture our drugs. We have no clue where our drugs are being made or which factories are making them.

    The FDA, for its part, insists that a drug is a drug and that differences among drugs that treat the same condition are not meaningful. But, Stockman argues that some manufacturing plants operate under much higher quality standards than others. And, even the distribution of a drug–does it sit out in the sun and bake for extended periods of time or is it protected?–can lead to differences in its efficacy.

    Americans are left in the dark. The lowest-cost drug in a given category might be the drug we are prescribed or the drug that our health insurer covers. But, it also might not be as effective or safe as another drug that costs more. We just don’t know.

    The FDA inspects drug manufacturing plants around the globe. But, during the pandemic, it inspected only three plants and was unable to inspect 1,000 on its list. What does that mean for the quality of our prescription drugs?

    On top of that, the US does not produce many key ingredients used in a number of drugs. Should we rely on India or China or some other country for those ingredients? The Biden administration apparently seems OK with that reliance.

    What’s clear is that the US needs to rethink its entire prescription drug policy. Drugs don’t work if we can’t afford them. They also don’t work if they are affordable but made with harmful ingredients or in a factory where they are contaminated. As it is, the FDA’s approval process for many new drugs does not indicate whether a drug is truly safe.

    Here’s more from Just Care:

  • Beware of faulty medical devices

    Beware of faulty medical devices

    Do not think that the medical device–be it an artificial hip, a pacemaker or mesh–your doctor proposes to implant is safe because the Food and Drug Administration (FDA) has approved its use. As I’ve written before on Just Care, there is a fair chance that you could be at serious risk. Fred Schulte reports for Kaiser Health News on the 28,000 lawsuits against medical device companies for selling faulty products, misleading providers about their products, failing to disclose product defects as required by law, paying physicians illegal kickbacks, and more.

    You rarely read or hear about medical device companies, but many are multi-billion dollar businesses. Like pharmaceutical companies, they are operating in a health care market that allows them to charge exorbitant prices for products that sometimes add little value or worse, cause serious harm. Despite the need for a more stringent FDA approval process of certain devices and a registry to ensure awareness of dangerous medical devices, the industry has done a brilliant job of keeping this from happening.

    One reason dangerous devices are in use lies with the FDA’s approval procedures. It allows medical device companies to design and distribute many new devices without testing. If they are substantially equivalent to another product already approved, they do not need to go through an approval process. But, the line between substantially equivalent and different enough as to be defective is blurry.

    It’s also often hard to know whether a device is safe even though there is a public database that is supposed to store information about faulty medical devices. The problem lies with the FDA, which also keeps a private database of information on medical device malfunctions and injuries that for some reason it does not deem fit for the public database. It literally keeps hundreds of thousands of incident reports secret. Consequently, doctors keep using these dangerous devices–artificial hips, pacemakers, mesh, etc.–on unsuspecting patients.

    And, physicians often rely on medical device salespeople when implanting a device. They often work in tandem with medical device salespeople to learn about them. While that might make sense in theory, it can be harmful to patients if the physician is not super sure of what he or she is doing. The sales reps are not legally required to have medical training or credentials.

    In one case, a surgeon relied on a Life Spine rep’s assurance that the surgeon would have the implants he needed mid-surgery to address a spinal issue, but he did not. The patient is claiming that, as a result, the surgeon implanted the wrong device and she suffered physical harm. Meanwhile, Life Spine, the sales rep and the surgeon are pointing fingers at one another, refusing to take responsibility for the harm.

    It’s still not possible to do the needed research to determine the frequency with which implants cause harm or which implants are dangerous. It’s also not possible to know which implants are the safest. A public FDA website at which reports of serious injuries from a medical device are posted has the following caveat: It could include “incomplete, inaccurate, untimely, unverified, or biased data.”

    Now, six multi-district federal cases have consolidated the more than 28,000 patient suits charging that medical devices caused injuries. For the health and safety of Americans, the federal government should be putting in place a smart and wholly transparent way to track injuries, a more robust approval process for devices, and a means of removing defective products from the market swiftly.

    Here’s more from Just Care:

  • Medicare to decide when new Alzheimer’s drug is covered

    Medicare to decide when new Alzheimer’s drug is covered

    As a rule, Medicare covers all federally approved treatments and medicines. But, there are always exceptions. Rachel Cohrs and Ed Silverman report for Stat that coverage for Aduhelm, the ridiculously expensive new Alzheimer’s drug, which is not at all guaranteed to be effective, will be one of them. In this case, Medicare is doing the right thing.

    The Food and Drug Administration (FDA) should never have approved Aduhelm as broadly as it did, if at all. In fact, it approved the drug against the advice of its advisors. After a large outcry, it narrowed its approval to people with mild cognitive impairments, the condition studied in the clinical trial.

    Whether the drug is clinically effective is still questionable, and it appears it can cause serious side effects, such as brain swelling and bleeding. Interestingly, two large hospital systems have just announced that they will not administer Aduhelm, Mount Sinai Health System in New York and the Cleveland Clinic in Ohio.

    The FDA does not approve drugs based on their cost. But, in this case, approving Aduhelm, which costs $56,000 a year, opens the door to driving up Medicare, spending and depleting the Medicare Trust Fund, at a rapid rate, as well as increasing the cost of Medicare supplemental coverage.

    It’s therefore good news that Medicare is making a national coverage determination with regard to Aduhelm. Medicare will determine who qualifies for Medicare coverage of Aduhelm and when.

    There’s some evidence that people with mild Alzheimer’s symptoms could benefit from the drug. If Medicare approved the drug for this cohort, it could cover as many as 1-2 million people. But, should it? To understand how this would impact Medicare spending, it would cost $29 billion to pay for the drug for 500,000 people.

    Since Medicare does not provide full drug coverage for any drug and copays can be significant, it’s not clear how many people with Medicare could even afford the drug.

    Stakeholders will be able to weigh in on Medicare’s decision. So, it will likely take nine months.

    Here’s more from Just Care:

  • New Alzheimer’s drug has questionable benefits and costs a small fortune

    New Alzheimer’s drug has questionable benefits and costs a small fortune

    In the “not so surprising” department, Axios reports that the FDA has just approved a new drug to treat Alzheimer’s disease that has questionable benefits and costs a small fortune. Unless Congress reins in drug prices asap, drug costs are likely to drive up Medicare spending to new heights in the coming years. Aduhelm, the Alzheimer’s drug, is projected to cost as much each year as the costliest eight Medicare drugs combined.

    Experts say that Aduhelm is far from sure to help any of the 6,000,000 people with Alzheimer’s disease. But, that won’t stop Biogen, its manufacturer, from promoting it wildly and broadly. It will do what it can to get as many doctors as it can to prescribe it. And, Medicare will be stuck paying a huge bill, even if the drug does not work.

    Still, the FDA approved the drug against the advice of its scientific advisory committee, reports The Atlantic. There is little clinical evidence that Aduhelm benefits people with Alzheimer’s. And, it has some serious side effects, including brain swelling and bleeding, which could undermine any of its benefits.

    Because the US does not regulate drug prices and because doctors can prescribe pretty much whatever drugs they please, drug manufacturers can drive up drug spending on drugs that offer very little, if any, value.

    Biogen says it will charge $56,000 a year for monthly infusions of Aduhelm. And, people will typically take the drug for three to 11 years, their usual lifespan after an Alzheimer’s diagnosis.

    Incredibly, the FDA approval of Aduhelm covers everyone with Alzheimer’s, even though the drug was only tested on a small subpopulation of Alzheimer’s patients. That would mean that it alone could cost Medicare around $112 billion a year if one-third of all people with an Alzheimer’s diagnosis are prescribed the drug. In 2020, Medicare spent $90 billion on all Part D drugs combined.

    People with Medicare and taxpayers would bear way more of the cost than you might think. The drug is administered by a doctor and covered under Part B. So, people will have 20 percent coinsurance. If they have supplemental coverage that picks up that cost, the premium for that coverage is likely to rise significantly.

    Senator Ron Wyden of Oregon, who heads the Senate Finance Committee, believes that Medicare should have the ability to negotiate a fair price for this drug, which it currently cannot do. He is leading the Senate Democrats on legislation that would give Medicare that power. Let’s see whether he can succeed.

    Here’s more from Just Care:

  • Biden administration aims to stop Pharma from preventing drug importation

    Biden administration aims to stop Pharma from preventing drug importation

    ABCNews.com reports on a Biden administration effort to ensure states can legally import drugs from abroad. You might have guessed that big Pharma is opposing drug importation by states. In this case, Pharma is trying to block Florida’s efforts to import drugs from Canada.

    The Biden administration is trying to dismiss a Pharma lawsuit against state drug importation. The administration argues that Pharma has no basis for filing a lawsuit to block state importation of drugs as the Biden administration has not approved importation to date. Interestingly, for once, the Republican governor of Florida, Ron DeSantis, is on the same side as the Biden administration.

    That said, DeSantis is quick to criticize the Food and Drug Administration for not approving state drug importation speedily. He’s a politician. And, he sees an opportunity to build political support around lower drug prices.

    Only Florida and New Mexico are currently seeking permission from the White House to import drugs from Canada. They believe it will save them and their residents tens of millions of dollars a year.

    Meanwhile, Pharma has only a couple of lame arguments against importation of drugs. Even though the US is able to import food safely and millions of Americans have already imported prescription drugs safely, it cries “safety” like the boy who cried “wolf.”  Of course, importation must be from verified pharmacies, but there are thousands of them around the globe.

    Here’s more from Just Care:

  • FDA is hiding information on supplements that are dangerous

    FDA is hiding information on supplements that are dangerous

    The FDA regulates dietary supplements, including beauty products, sexual enhancement products, and workout supplements. But, it does not make a determination about the safety or efficacy of these supplements before they become available to the public. Because these supplements can literally kill people, the FDA is supposed to disclose reports of harm from supplements. Why is the FDA hiding information about supplements that are dangerous?

    To protect Americans, the FDA has a database, CAERS, that is supposed to include information on supplements that are reported dangerous, including product complaint reports. CAERS is open to public scrutiny because Americans should know when a supplement is dangerous.

    But, Consumer Reports has found that the Trump administration is not disclosing information about many supplements that are dangerous; prior administrations have also not done so to the extent required. According to Consumer Reports, the CAERS database does not disclose the names of hundreds of manufacturers of products that have been reported to cause harm. Rather, the FDA is giving many manufacturers an exemption, putting the businesses of manufacturers ahead of the safety of Americans.

    The FDA has always exempted a small class of products from being reported for public view (<5 percent) in an effort to encourage manufacturers to report consumer complaints to the FDA. The FDA appears now to be applying this exemption far more broadly, counter to FDA policy.

    With products that cause death or hospitalization, a manufacturer must let the FDA know. And, the FDA is supposed to make that information available to the public. Also, when an individual or a physician submits a report about a product, the product’s name is supposed to appear in the CAERS database.

    After analyzing documents released because of a Freedom of Information Act request, Consumer Reports found that the FDA exempted more than 400 supplements, even though they were reported to have caused hospitalizations or deaths. The FDA is now saying that these reports were “mislabeled,” acknowledging that the products should have been disclosed.

    The CAERS database came into being in 2003 to make consumers aware of safety issues from supplements. But, in 2015, the FDA began exempting 15 percent of product names from public view. During the Trump administration, those exemptions have doubled to more than 30 percent of product names.

    Millions of Americans take supplements on a daily basis. And, many swear by them. But, there is little scientific evidence that they provide benefits in most cases. And, lots of evidence that they can cause serious harm.

    On top of the failure of the CAERS database to disclose information critical to the health and safety of Americans, the CAERS database is hard to search. The FDA also operates a FAERS database in which adverse events related to drugs are reported. That database is easily searchable.

    Here’s more from Just Care: