JustCare

Tag: Safe

  • Forever chemicals take big toll on our health

    Forever chemicals take big toll on our health

    Tens of thousands of miles from us, between Iceland and Norway, in the Faroe Islands, scientists are finding the toxic effects of “forever chemicals” on residents, reports The New York Times. Make no mistake, toxic “forever chemicals” are traveling long distances to get to the Faroe Islands, And, still, they appear to be doing grave harm to the health of Faroe Island residents.

    Scientists in the Faroe Islands have been studying how mercury in fish affects pregnant women and their children for nearly 4o years. They have collected blood and hair samples from more than 1,000 women and children that they can test for all sorts of chemicals. They have found low levels of mercury in women’s wombs. The risk of learning and memory impairments is high for their children.

    Fourteen years ago, the scientists began looking at the effects on these people from exposure to “polyfluoroalkyl substances, which the FDA calls PFAS and classifies “as safe,” the “A” and “S.” You can find them in countless products we use every day. No one knows precisely what harm they cause us, but we do know that they damage the immune system in rats.

    In the US, the FDA is not required to test the chemicals in our food. The Federal Food, Drug and Cosmetic Act requires the FDA to create a system for studying chemicals added to foods before they come to market and to reassess their safety when new evidence suggests it is needed. But, the FDA can and has allowed companies that add these forever chemicals to our food and drinks to review their safety. And, the FDA lets these companies’ experts determine whether the chemicals are generally recognized as safe, “GRAS.”

    The scientists in the Faroe Islands knew from lawsuits in the US that some PFAS caused high cholesterol, cancer and ulcerative colitis, among other grave health conditions. The scientists found that children in the Faroe Islands had fewer antibodies than normal from tetanus and diphtheria vaccines.

    But, the difference between the children in the Faroe Islands and people in the US who filed lawsuits was significant. The US citizens had high level exposure to the PFAS toxins because DuPont had dumped PFAS waste into the Ohio River in high volumes that affected the air and drinking water. The children in the Faroe Islands had extremely limited exposure to these chemicals.

    More than 40 years ago, DuPont’s own studies showed that significant exposure to PFAS causes abnormal liver function and other serious harm. Its own workers were affected. One worker had a child with a single nostril and impaired eyes.

    For the most part, our federal government continues to allow the use of these toxic chemicals in millions of products, About one fifth of our exposure to these chemicals comes from tap water. The rest is in our food, in the air, in cosmetics and other skin products, furniture, rugs, candy wrappers and raincoats. The European Union found PFAS in organic eggs.

    Of the thousands of PFAS toxins, the Environmental Protection Agency has identified only two that are “likely to be carcinogenic to humans.” The EPA says its goal is to eliminate them from tap water. Its proposed rule is not yet approved. But, the EPA says the rule “will prevent thousands of serious PFAS-attributable illnesses.”

    Meanwhile, DuPont and 3M agreed to invest $11.5 billion into cleaning public water, as a result of lawsuits. And, 3M says it is ending production of all PFAS in the next 18 months. There’s some pressure to do so, if not from the EPA. The European Chemicals Agency is proposing to forbid all PFAS in the European Union.

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  • Medical and health misinformation abounds

    Medical and health misinformation abounds

    Medical and health misinformation abounds, and it’s not going away. The government should do more to address some of the misinformation. But, as with all advertising and promotion, you need to assume that what you are hearing or seeing or reading might not be true, before acting on the information. Try to find independent sources you can trust.

    There are a few trustworthy sources for determining whether a drug, vitamin supplement or medical device or medical service is safe and effective. For good information on health care and policy, I go to cochrane.org. Cochrane is a non-profit independent organization that studies all the available reliable data to determine what’s working or not working. For example, if you go to cochrane.org to look up different vitamin supplements, you’ll learn a lot about the lack of evidence that most of these supplements work.

    If the question is whether a medical device is safe and effective, you can begin by looking on the Food and Drug Administration’s web site to see whether it has been recalled. Unfortunately, that won’t tell you the whole story because the FDA has not recalled some medical devices it has approved that can cause serious harm.

    Similarly, there are lots of prescription drugs that are FDA-approved that may not be safe and effective.

    Stat News reports on FDA action–truly inaction–to address a lot of misinformation. Some researchers argue the FDA must do more to police health information and ensure drug labels are accurate. At the same time, the researchers recognize that the FDA does not have the tools, resources or power to undertake this work.

    In some cases, the FDA might be infringing on people’s free speech rights under the first amendment of the constitution. Moreover, the internet enables people to make inaccurate claims that reach tens of millions of people. “Counteradvertising,” as it is sometimes called, will never do enough to keep the misinformation from taking hold.

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  • 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:

  • Coronavirus: Is it safe to dine out?

    Coronavirus: Is it safe to dine out?

    Winter has come, and the coronavirus continues to rage. We are all tired of cooking and restaurants are trying everything in their power to lure us out. Their solution is every which kind of outdoor dining structure. Is it safe to dine out when your town allows it?

    In their attempts to protect people from COVID-19, local governments have not made it easy for restaurants. They want to minimize the likelihood of spreading the virus. Many do not allow restaurants to serve food indoors or outdoors. Takeout is the only option.

    There’s no question that it’s better to eat at home. But, if you want to go out for a meal, avoid indoor dining. Because it’s cold out, some restaurants are offering outdoor dining designed to keep you safe and warm.

    Kaiser Health News reports that some people have the option of having a meal inside an igloo, a tent or a yurt. To stay afloat, some restaurants are trying to make these structures comfortable as well as safe for dining out. Already, more than 100,000 restaurants have closed their doors, many permanently, unable to find a way to attract customers.

    One fine dining restaurant in Seattle transformed its parking lot into a yurt village, with a fireplace and tents. You have your own private flapped tent in which to dine. And, it still won’t allow you to dine at the restaurant unless your temperature is normal. The cost: $135 for a four-course meal.

    A fine dining restaurant in New York City has also built a yurt village for its guests. The cost: $165 for a prix-fixe menu, excluding the wine, which is another $80 a person for the pairing. Once you book, you are locked in. Upfront payment. No cancellations.

    Keep in mind that even if dining is outdoors in yurts, you are not 100 percent safe. Your safety turns on whose air you are breathing. The coronavirus travels through the air and can be picked up from touching an infected surface.

    Some restaurants rely on transparent igloos for safety. They can be imported from Lithuania. One owner uses a hot air cannon after diners leave to decontaminate the air of any lingering bacteria.

    As you might gather, the safest outdoor dining is purely outdoors, with no walls, no roof. Heaters apparently deliver good ventilation because they cause the air to rise and circulate.

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  • 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.

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