JustCare

Tag: FDA

  • Improving our food would improve our health

    Improving our food would improve our health

    Back in January, the Food and Drug Administration (FDA) proposed a rule that would change food labeling in ways that could improve our health. More recently, Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr., proposed that the FDA reconsider its rule permitting substances Generally Recognized As Safe into our food. Will these changes happen and, if they do, will they improve our health?

    Both the HHS and the FDA say they are committed to helping Americans know exactly what’s in the food they are eating. Eliminating substances “Generally Recognized As Safe” (GRAS) from our food supply would be a huge step towards achieving this goal. GRAS tend to be chemicals in our food, about which we know very little, if anything. They might not be safe.

    Eliminating GRAS from our food would also make it easier for the FDA to oversee our food supply. “For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public,” said Secretary Kennedy. “Eliminating this loophole will provide transparency to consumers, help get our nation’s food supply back on track by ensuring that ingredients being introduced into foods are safe, and ultimately Make America Healthy Again.”

    But, Kennedy is cutting 20 percent of the FDA’s workforce, reports Christina Jewett for the New York Times. Consequently, 3,500 fewer people are ensuring our food safety and medical device safety, approving new drugs, preventing outbreaks of foodborne illnesses, and much much more. Without strong FDA oversight, there’s much to fear about the safety of our food and health care.

    Moreover, the FDA will face strong pushback from the food industry. Today, the food industry can simply inject substances GRAS into foods without even letting the FDA know. Companies can self-affirm that new ingredients in foods are safe. If RFK Jr. prevails, food companies would have to notify the FDA of their plan to use GRAS substances in their foods and provide the FDA with whatever safety data they had before they could use these substances.

    Meanwhile, prior to President Trump taking office, the FDA issued a proposed rule that would require companies to put nutrition labels on the front of food packages to help Americans better understand the ingredients in their foods. The rule would change nutrition labels so that they reflected whether a product has low, medium or high levels of sodium, and saturated fat, reports Sarah Todd for Stat News.

    If finalized, the nutrition labeling rule might might lead food companies to produce healthier food. The FDA, under the Biden administration, claimed that the rule would help fight chronic disease, including cancer and diabetes. These diseases are associated with diets that are high in saturated fats, salt and added sugars. Four in ten Americans have two or more chronic conditions and six in ten have at least one chronic condition.

    Here’s more from Just Care:

  • As HHS head, will RFK Jr. take on big insurers?

    As HHS head, will RFK Jr. take on big insurers?

    President-elect Donald Trump has nominated Robert F. Kennedy Jr. as the next head of the US Department of Health and Human Services, reports Sheryl Gay Stolberg and Susanne Craig for The New York Times. The choice is to be expected given RFK Jr.’s strong alliance with Trump. If the Senate confirms the nomination, as expected, what will it mean for the health of our nation?

    RFK Jr. is an anti-vaxxer, critical of our public health agencies, over which he will preside. It has been reported that he might try to end legal protection for pharmaceutical companies that release vaccines, likely deterring production of new vaccines. So, our public health is likely at serious risk.

    But, Kennedy also has promised to eliminate the corporate control of our federal food and health agencies, if confirmed. And, that is desperately needed.

    Kennedy correctly describes the Food and Drug Administration (FDA) as controlled by corporations. In his words, “The F.D.A. is just a sock puppet to the industries it is supposed to regulate.” The FDA gets “user fees” from pharmaceutical and medical device companies, which represent about half its budget. Not surprisingly, it behaves in ways that would make you question its independence.

    Pharmaceutical company stocks have fallen in value since Trump announced Kennedy as his pick for HHS Secretary. Big Pharma is likely right now trying to derail Kennedy’s nomination. But, it’s hard to imagine that the Republican Congress will oppose any of Trump’s cabinet nominees.

    It’s also clear that RFK Jr. will only have as much latitude to take on the big health care corporations as Trump allows him. What Trump will allow him to do remains an open question.

    Among some of RFK’s most extreme positions is a desire to prosecute The Lancet and the New England Journal of Medicine, two of the most respected medical journals in the country, under the federal anti-corruption statute. Kennedy claims that they publish “phony science.”

    Kennedy also has called for eliminating fluoride in public water supplies, a position counter to the science. The Centers for Disease Control and Prevention (CDC) calls water fluoridation one of the greatest public health achievements. It prevents tooth decay.

    Here’s more from Just Care:

  • Beware of medical devices that the FDA has recalled

    Beware of medical devices that the FDA has recalled

    David Hilzenrath reports for KFFHealth News on how defective medical devices end up remaining in use. Even when the FDA sends out notices about medical devices that can cause serious injuries or even death, physicians might be using them. Inexplicably, manufacturers and the FDA do not end their use or effectively recall them from use.

    In most cases, when an agency recalls a product, be it food or an automobile or a crib, it asks that customers return the product to its place of purchase for repair or to discard it. But, an FDA medical device recall does not mean that the product is actually recalled. Rather, a recall could mean something other than an end to a product’s use. It can mean a fix of some sort, be it a repair or adjustment or inspection of a device.

    In one case, Abbot, a medical device manufacturer, explained that instead of removing a defective implanted medical product from the market, it changed instructions on how to use it and required physicians to get training before implanting it.

    Of 338 medical device recalls between 2019 and 2034, 164 were “corrections.” Only 174 products were actually taken off the market. When it does not remove a medical device from the market, the FDA says it is because the frequency or severity of the bad consequences from the product is not great or that the fix is effective and the benefits to patients are greater than the loss of the product.  To be sure, there are risks from removing implanted devices from patients.

    The takeaway: Be sure to look into any medical device your doctor recommends before agreeing to it. I have reported several times, including here and here and here, on dangerous medical devices that the FDA has failed to remove from the market, to the detriment of patients, allowing manufacturers the ability to “fix” the defects at some risk to patients.

    Here’s more from Just Care:

  • Don’t trust TV drug ads

    Don’t trust TV drug ads

    Elisabeth Rosenthal writes for KFF Health News about why you should not trust drug ads on TV. Ignore the celebrity endorsements by Lady Gaga and others; they won’t tell you about a better less expensive drug. If our government were not in the pocket of the pharmaceutical corporations, it would ban all direct to consumer drug advertising as every country other than the US and New Zealand do.

    Pharmaceutical companies spend huge amounts of money to sway you to buy their drugs because their ads work really well, even when the ads promote drugs that are of little value. Indeed, pharmaceutical companies now spend more than $1 billion a month on these ads. They are among the biggest spenders of TV ads.

    The Clinton Administration is responsible for allowing these ads, which had been banned. The FDA thought it could somehow keep the drug companies from misleading people by saying ads could not be misleading and had to list side effects. Really?

    Rosenthal reports on University of Colorado professor Michael DiStefano’s recent study of best-selling drugs, which found that the pharmaceutical companies spent more on ads targeted to individuals, featuring drugs with fewer benefits, than on ads for doctors. DiStefano is concerned: “I worry that direct-to-consumer advertising can be used to drive demand for marginally effective drugs or for drugs with more affordable or more cost-effective alternatives.”

    Thankfully, five of the ten drugs that will have Medicare negotiated prices beginning in 2026, are drugs that the pharmaceutical corporations spent the most advertising to patients.

    The government’s legal challenges to PhRMA’s misleading ads, even by the former Trump Administration, are not easy to win. PhRMA claimed that a requirement to disclose a drug’s list price in an ad violated first amendment rights and prevailed.

    New FDA requirements sound great, but they are so vague and subjective as to be meaningless; moreover, the FDA cannot enforce them effectively. As of November 2023, PhRMA consumer ads must provide a “non-misleading net impression about the advertised drug.” Drug ads should be “clear, conspicuous, and neutral.”  “Audio or visual elements that might interfere with the consumer’s understanding” is not permitted and and anything in writing must be “easy to read.”

    The FDA does not require the pharmaceutical corporations to submit ads for approval before releasing them. The drug companies are expected to self-police. And, the FDA does not have the money or the power to hold pharmaceutical companies to account when they misled. Each year over the last five years, the FDA sent out an average of six “warning letters.” And, it’s not at all clear that the companies receiving those letters did anything about their misleading ads.

    The FDA now has a Bad Ad Program for physicians, The program trains them on misleading ads and gives them a hotline to call to report misleading ads: 855-RX-BADAD. Given the FDA’s limited resources and power, it’s hard to imagine that will do any good. The FTC apparently does not have the power to protect consumers from false and misleading drug ads.

    For the public health, Congress should ban these ads altogether.

    Here’s more from Just Care:

  • FDA won’t approve MDMA for treatment of PTSD

    FDA won’t approve MDMA for treatment of PTSD

    The FDA isn’t approving MDMA (sometimes known as the party-drug ecstasy or molly) for the treatment of post-traumatic stress disorder or PTSD, a mental illness. Some Republican and Democratic members of Congress on the Congressional Psychedelics Advancing Therapies (PATH) Caucus believe the FDA made a mistake. In their view, MDMA could save lives.

    In particular, many think that veterans with PTSD would be well served through MDMA. Other treatments often do not work. Veterans very much supported FDA approval of the psychedelic drug. And, there is mounting support from the public for FDA approval of MDMA. Thirteen million Americans suffer from PTSD.

    The FDA did not rule out future approval of MDMA. Rather, it requested that Lykos Therapeutics, which conducted the clinical trial, conduct a third phase 3 trial to investigate further the safety and efficacy of MDMA. The first two trials suggested MDMA was effective for treating PTSD, but the FDA’s advisory committee claimed that data on adverse events were missing and that the research was biased. A third trial will take several years to complete.

    Olivia Goldhill reports for Stat News that the Institute for Clinical and Economic Review (ICER) determined back in March that evidence supporting MDMA therapy for PTSD was “insufficient.” It posited that there could have been clinical trial misconduct. Trial participants told ICER researchers about “severe negative outcomes.” These outcomes were not reported in the trial data.

    Haleema Shah reports for Vox that MDMA was created decades ago now in a home laboratory, and since then, people have used it illegally. People who use it say that it fills them with love and empathy. Some say that people with PTSD who use it for 18 weeks are relieved of symptoms that other medicines and talk therapy cannot accomplish.

    That said, there is evidence that MDMA can have serious health consequences, including rapid heart rate and other heart conditions.

    Here’s more from Just Care:

  • 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.

    Here’s more from Just Care:

  • Will FDA approval of Wegovy to treat heart conditions mean more people with Medicare can fill a weight-loss prescription?

    Will FDA approval of Wegovy to treat heart conditions mean more people with Medicare can fill a weight-loss prescription?

    The FDA recently approved Wegovy, a weight-loss drug, to treat overweight people with heart conditions. Will that mean that more people with Medicare will get their weight-loss drugs covered? Maya Goldman reports for Axios on what the Centers for Medicare and Medicaid Services (CMS), which oversees Medicare, as well as the insurers offering Medicare Part D prescription drug coverage, are considering.

    At the moment, CMS has not decided whether Medicare will cover Wegovy as a treatment for overweight people with heart conditions. To date, Medicare has not covered any weight-loss drugs simply for the purpose of helping people lose weight. But, Medicare does cover weight-loss drugs as a treatment for people with diabetes.

    Medicare, by law, covers only treatments for medically reasonable and necessary services. CMS does not consider treatment for weight loss as reasonable and necessary. Treatment for a heart condition, much like treatment for diabetes, is very different.

    About 40 percent of people with Medicare have heart conditions. That’s more than 24 million people. And, likely a sizeable number of them are overweight. So, Medicare might end up covering Wegovy for them.

    Of note: Wegovy costs about $1,200 a month. Covering it for even four million more people will likely cause Medicare spending to balloon. Fortunately, people with Medicare should not see their costs balloon. Beginning in 2025, people’s annual out-of-pocket costs for covered prescription drugs will be capped at $2,000.

    For now, insurers offering Medicare Part D prescription drug coverage are waiting for CMS to rule on the conditions under which Medicare will cover Wegovy. Part D insurers could, of course, decide to cover Wegovy without waiting for CMS, but that would cost them a bundle. Their Medicare payments for this year are already set.

    Here’s more from Just Care:

  • FDA allows Florida to import lower-cost drugs from Canada

    FDA allows Florida to import lower-cost drugs from Canada

    Finally, in some part thanks to former President Trump and Governor Ron DeSantis, as well as to the Biden Administration’s Federal Drug Administration (FDA), the US plans to open its borders to drug importation, reports Christina Jewett and Cheryl Gay Stolberg for the New York Times. While that is not a long-term fix to unconscionably high drug prices in the US, it is a terrific first step–unless the pharmaceutical industry succeeds at blocking these drug imports.

    To be clear, the FDA only has approved drug importation from Canada. And, as of now, only the state of Florida has approval. But, it is the camel’s nose under the tent and could save Florida as much as $150 million in drug costs in its first year.

    Interestingly, while the Biden Administration supports drug importation, it took a lawsuit by the state of Florida against the FDA to get the the needed federal approval.

    Americans already can buy drugs legally directly from Canadian pharmacies for personal use, but insurers are not required to cover those drugs. They still don’t. But Florida has approval to buy drugs for enrollees in its Medicaid program, people using its health clinics, and people in prison.

    It’s also not clear whether drug importation from Canada will work better for states in theory than in practice. Canada might not have enough supply to provide the drugs Florida needs, let alone the drugs other states will also want to purchase once they have FDA approval.

    You can bet your bottom dollar that Pharma is pulling out all stops to keep drug importation from happening. It plans to bring a lawsuit to prevent Florida from importing drugs from Canada. Moreover, some Canadian drug wholesalers have signed contracts with pharmaceutical companies agreeing not to export their drugs. In addition, Canada does not have a bottomless supply of drugs.

    Time will tell how this story unfolds. Drug importation from Canada was a long time coming. The New York Times reports that Congress passed legislation allowing drug importation 20 years ago, but it is only now that the administration is implementing it. Allegedly, there were “safety” concerns. More likely, there were concerns about PhRMA’s wrath.

    To be clear, patient safety concerns abound in the US because people cannot afford the drugs they need. Too often, they die as a result. And, even more often, they become sick or disabled because they cannot afford to fill their prescriptions.

    There are no reports of people harmed from importing drugs from abroad. Nine million Americans import drugs from abroad every year without incident.

    Colorado, Maine, New Hampshire, New Mexico, North Dakota, Texas, Vermont and Wisconsin have passed laws to allow their states to import drugs and likely many more will do so. Canada should not be the only foreign provider. Many drugs taken in the US are manufactured in India, China and elsewhere. Americans should be permitted to import drugs from verified pharmacies in any country.

    Americans support drug importation. Of course, we do. We import food safely from abroad, and automobiles, and electronics and more. There’s no good reason that we cannot import prescription drugs safely. And, anyone who supports competition should support drug importation, especially since drugs in the US often cost four times more than drugs in other developed countries.

    The big problem with drug prices in the US is that PhRMA can charge pretty much what it will for brand-name drugs. There’s little competition. PhRMA also can keep low-cost generic alternatives off the market for years.

    The Inflation Reduction Act allows our government to negotiate drug prices, which is arguably the best way to bring down drug prices in the US. But, it only allows drug price negotiation for 10 high-priced drugs in the first year, and only for people with Medicare. It’s good, but way less than what we need.

    And, while helpful, Medicare Part D drug plans can still cost you a bundle. If you want to keep your drug costs down, you need to compare your drug copays against the full cost of your drugs at Costco and other low-cost pharmacies. In some cases, you’ll pay less through Costco as this JustCare reader does.

    Before it can begin importing drugs from Canada, Florida must specify the drugs it will import to the FDA and explain how it will ensure they are not counterfeit. Florida also must relabel the drugs.

    Meanwhile, the Canadian government is none too happy about exporting drugs to Florida. The Canadian government could step in if it does not liking the consequences of drug exports. There is understandable worry that a country with fewer than 40 million people will find itself without needed drugs if it exports them to a state with 22 million people, let alone to multiple states with tens of millions more people.

    Here’s more from Just Care:

  • Importing drugs from abroad should be legal

    Importing drugs from abroad should be legal

    In a new paper, Stephen Salant, a professor at the University of Michigan, makes a compelling case that people in the US should be able to import drugs from abroad and that it is safe to do so.

    Salant explains that people in the US spend much more than people in other wealthy countries for the identical brand-name drugs. Drug prices are lower in other wealthy countries because their governments negotiate with drug manufacturers. The lower prices abroad are still a lot higher than the cost of producing the drugs. And, drug manufacturers invest millions to sway Americans to believe that it’s unsafe to import drugs from abroad.

    We typically pay three and a half times more for a brand-name drug than people in other countries. Most other wealthy countries use price controls to keep prescription drug prices down. They either value a drug based on its cost-effectiveness. Or, they use reference pricing to bring drug prices down.

    Other countries still pay prices than can be as much as 100 times more than the cost of producing drugs. Western Europeans pay a minimum of $40,000 for a 12-week course of Sovaldi to treat hepatitis C. But, Sovaldi costs its manufacturer $68-$136 to produce that course of treatment.

    At the same time, Pharma relies on non-profit shill groups to argue that imported drugs could be counterfeit and unsafe and sway public opinion. Consumer protection is a pretext, an argument to keep drug prices high and generate enormous profits for drug companies. Pharma hired former FBI Director Louis Freeh’s firm to say that importing drugs would “open a new, unregulated pipeline into the United States.” But, at the time, 16 states simply were proposing to import drugs from highly regulated prescription drug markets abroad.

    People can already buy drugs from abroad when they travel abroad, as well as online. And, big retail outlets like Amazon and Costco theoretically could bulk purchase drugs from abroad safely and sell directly to people in the US. All the evidence suggests that these drugs are as safe as drugs people buy in the US.

    Here’s the truth: “The FDA has never reported a death or adverse reaction suffered by any patient in the U.S. who has personally filled his valid prescription online or in person from a pharmacy licensed in another high-income country.” The government has never prosecuted people in the US for importing drugs for personal use, even though it is illegal. But, the government does take action against companies that try to buy drugs abroad for resale in the US.

    “Asking sick people to finance drug innovation, which is of value not only at home but abroad, is ethically indefensible,” argues Salant. “The burden falls heaviest on sick Americans since our prices are by far the highest. People currently in good health should shoulder more of the burden. Increased subsidization, financed by general taxes at home and abroad is, in my view, a step in the right direction.”

    Here’s more from Just Care:

  • How to treat a runny nose?

    How to treat a runny nose?

    Are you taking DayQuil or Sudafed PE for a runny nose? It’s probably time to stop. An FDA panel recently declared that the decongestant in many over-the-counter oral cold medicines doesn’t work, reports the American Academy of Family Physicians.

    The decongestant in many over-the-counter oral cold and allergy medicines that appears to be no more than a placebo is phenylephrine. It’s been around for many years now. And, you can find it in dozens of brand-name cold and allergy medicines you buy at the drugstore.

    It took the FDA more than three decades to come out with a ruling. Experts have been calling for the FDA to make a finding about the lack of efficacy since at least 1992, reports Christina Jewett for The New York Times.

    Sudafed PE, TheraFlu, Vicks NyQuil Sinex Nighttime Sinus Relief and Benadryl Allergy Plus Congestion are just a few of the common oral cold remedies that include phenylephrine. Shockingly, phenylephrine is more popular than any other oral decongestant in the United States. It led to just under $2 billion in sales last year.

    If phenylephrine worked, it would keep down the swelling in your nose. But, when you take it orally, most of it does not travel to your nose. So, it cannot end your congestion; your nose remains stuffy.

    The FDA nows says that oral phenylephrine cannot be categorized as generally safe and effective since it is definitely not effective. As a result, manufacturers of decongestants with oral phenylephrine might have to pull their cold medicines that include it from store shelves. The FDA has not ruled on that yet.

    Phenylephrine has side effects, including  headaches, inability to sleep and agita. It can also sometimes increase blood pressure.

    Note: Phenylephrine sprays do work because they travel directly to your nasal passages. Moreover, many of the products containing oral phenylephrine contain other products that can help with cold and allergy symptoms.

    Here’s more from Just Care: