JustCare

Category: Drugs and alcohol

  • Drug prices: It’s time for the federal government to step in

    Drug prices: It’s time for the federal government to step in

    Fran Quigley writes for Common Dreams about the need to end pharmaceutical company monopolies if drug prices are going to come down. The federal government right now could exercise its “march in” rights and do just that if it chose to. But, it is so beholden to the pharmaceutical industry, it is not clear when it will.

    We do not have a free market for prescription drugs. Pharmaceutical companies have monopoly pricing power for brand-name drugs only because Congress has given them patent protections. Without those protections, drug prices would come down substantially.

    It costs drug companies pennies to manufacture a drug. But, because of their patent protections, pharmaceutical companies can charge prices that are literally thousands of times more than it costs to manufacture and distribute the drugs. And, insurers pay them; they profit from these high prices.

    Today, we are paying for the discovery of many drug innovations, from which pharmaceutical companies profit handsomely, with our tax dollars. The National Institutes of Health funds most drug research. In fact, it has funded research for every new drug developed in the last ten years.

    The consequence of pharmaceutical patent protections: A large proportion of Americans cannot afford the medicines they need.

    The House of Representatives passed HR3, which would allow the government to negotiate the price of hundreds of drugs over the next 10 years. And, it would limit the price of these drugs to around what other wealthy countries pay for them. But, the Republican-controlled Senate has let this legislation sit on the cutting room floor.

    Until HR3 or other legislation is enacted to lower drug prices, the Department of Health and Human Services should exercise its power to make drugs affordable for everyone. It has the power to issue licenses to other drug companies to manufacture and distribute drugs that are priced too high–“compulsory licensing” power. The government also has the power to directly manufacture these drugs. Either way, the patent holder is paid a fee. However, the government has not used this authority.

    The government’s power stems from the Bayh-Dole Act of 1980. It gives the federal government “march in” rights to issue a compulsory license for any drugs discovered with federal funding. The only condition is that the drug must be deemed not to be available on “reasonable terms.”

    We should also nationalize the vaccine industry and give government the ability to innovate and produce critical medicines. By so doing, we would not have to rely on the pharmaceutical industry for critical drugs.

    There is no reason we need to be beholden to Big Pharma. The US has used compulsory licensing as a threat many times before. In dozens of instances, prices have come down. But, President Trump’s administration won’t use it or even threaten to. Instead, they force millions of Americans to go without needed medicines they cannot afford.

    Here’s more from Just Care:

  • Warning: Your hip replacement could kill you

    Warning: Your hip replacement could kill you

    Jeanne Lenzer writes for the New York Times about the danger of getting a hip replacement. In some cases, your hip replacement could cause serious harm. In general, as we have reported, FDA-approved medical devices may not be safe.

    Stephen Tower, an orthopedic surgeon, had a metal-on-metal hip implanted, the ASR XL, made by Johnson & Johnson. Dr. Tower specializes in complex hip replacements, but he was not aware that the hip he chose for himself had a serious defect. He ended up needing another surgery because of the pain his artificial hip was causing him.

    Dr. Tower’s artificial hip had turned the tissue around it black. The artificial hip leaked cobalt causing Dr. Tower to suffer from metallosis. Muscles, tendons and ligaments near the hip were destroyed. Worse still, Dr. Tower suffered damage to his heart and brain.

    Afterwards, Dr. Tower warned Johnson & Johnson of the serious defect in the hip but the medical device company did nothing about it. Rather, it continued to market metal-on-metal hips. It finally withdrew the ASR XL model from the market in 2010, but it sold another metal-on-metal hip, the Pinnacle, until 2013.

    Thousands of people received a Johnson & Johnson metal-on-metal hip replacement during this time. Six of them won a $247 million verdict because of the Pinnacle’s harmful side effects and because Johnson & Johnson did not warn doctors or patients about these side effects.

    Unfortunately, these metal-on-metal hips are one of many FDA-approved medical devices on the market that put patients at risk for dangerous side effects.  A provision of the Federal Food, Drug and Cosmetic Act, known as 510(k), allows medical device companies to market many new products without having to do any clinical trials. All that the medical device company need do is claim that the device is “substantially equivalent” to a medical device already on the market.

    While the FDA can recall the product if it is deemed to cause harm, it can take a long time for that recall to happen. Hundreds of thousands of people can end with the device implanted before it is recalled. And removal of the device once recalled can also jeopardize patients’ health.

    In 2016 alone, the FDA recalled 117 medical devices because of a “reasonable probability” that they would “cause serious adverse health consequences or death.”

    Medical devices that undergo clinical trials are also not guaranteed to be risk free. Indeed, the FDA may conditionally approve them even when the clinical trials show potentially harmful side effects, including a high death rate. That’s what happened with a Cyberonics device designed to treat epilepsy. The FDA did not require that patients who received this device be told about the risk of dangerous side effects.

    The FDA’s approval process appears to put profits before patients. Yes, more devices get to market more quickly. But, at what cost to human life and health?

    Here’s more from Just Care:

  • One in seven older adults experience harmful drug side effects

    One in seven older adults experience harmful drug side effects

    More than nine in ten older adults take at least one prescription drug; And, half of all older adults take four or more prescription drugs, some of which they may not need. On top of that, many take over-the-counter medications and supplements. Kaiser Health News reports that more than one in seven older adults experience harmful drug side effects. Talk to your doctor about all the drugs you’re taking, why you need them, and whether you can stop taking one or more of them.

    Good primary care doctors and geriatricians oversee their patients’ drug use and try to “deprescribe,” reduce the number of prescriptions their patients are using, eliminating those that are unnecessary or inappropriate. Often, with drugs, less is more. Hundreds of new drugs are harmful or ineffective. And, one in three recently approved drugs may have harmful side effects.

    The most common side effects from multiple medications are dizziness, confusion and falls. But, some side effects are life-threatening. Here is a roundup of Just Care posts on commonly used prescription and over-the-counter drugs, as well as supplements, that have been linked with serious side effects.

    Keep in mind that FDA approval of a drug does not mean that it is safe, only that the clinical trials pre-FDA approval showed that the drug offered a clinical benefit. If possible, stay away from drugs that have been on the market fewer than ten years. Typically, it takes 4.2 years from FDA approval for detection of a new risk for a novel drug. But, it could take ten years after FDA approval for popular drugs to be pulled from the market.

    Here’s more from Just Care:

  • Should you be drinking grapefruit juice?

    Should you be drinking grapefruit juice?

    Grapefruit juice, which is filled with vitamin C and potassium, can be part of a healthy diet. But, according to the FDA, you might want to avoid drinking grapefruit juice if you are taking certain prescription drugs and over-the-counter drugs to avoid harmful side effects. Speak with your doctor or pharmacist about possible interactions.
    Grapefruit juice and, more generally, citrus fruits and juices can interact with certain medications and cause harmful  and even dangerous side effects. People with high blood pressure and arrhythmia should be particularly cautious. Sometimes, a substitute medication does not cause these side effects.
    Potentially harmful interactions can occur regardless of when you eat or drink citrus products. But, dangers side effects depend on your body, the drugs you take, and how much juice you drink. Citrus products contain chemicals that can keep enzymes from doing their job in your digestive system. They therefore may not allow drugs to leave your body when they should, putting too much of the drugs in your blood and causing you harm. Or, your medicines may not remain in your body as long as they should, failing to work properly.
    A wide range of drugs can interact with citrus products in harmful ways, including statins like Zocor and Lipitor that lower cholesterol. Grapefruit juice and other citrus products can also cause harmful interactions with prescription drugs like Procardia and Adalat, which treat high blood pressure, and buspirone, which treats anxiety, and some antihistamines like Allegra.
    Of course, vitamins are important for your health and well-being. Most people can get all the vitamins they need from a healthy diet. And, you can save money avoiding vitamin supplements. There is little evidence that vitamin supplements provide the nutrients most people need. And, they too, present risks.
    Here’s more from Just Care:
  • One pharmacy uncovers dangerous chemicals in some common drugs

    One pharmacy uncovers dangerous chemicals in some common drugs

    A small pharmacy based in New Haven is testing the prescription drugs it dispenses for safety. And, it is uncovering dangerous chemicals in some common drugs. Talk to your doctor about the safety of the drugs you’re taking.

    We know that some drugs the FDA has approved have turned out not to be safe. But, how many others are unsafe that have not been reported? Carolyn Johnson reports for  The Washington Post that Valisure, a small online pharmacy, is checking every drug it sells before dispensing it.

    Since it began testing the drugs it dispenses, Valisure has found a sea of drug safety issues and other prescription drug problems. It rejects more than one in ten drugs it tests because it finds either that they contain contaminants or otherwise do not perform as expected. For its part, the FDA says that drug safety is not an issue with its approved drugs.

    Valisure recently found that Zantac, a best-selling drug, is less safe than many people thought. It contains a cancer-causing chemical. Since Valisure’s discovery, 40 countries have stopped allowing it to be sold.

    The FDA has asked for the recall of Zantac and other products with ranitidine and nizatidine. Pepcid, Tagamet, Nexium, Prevacid and Prilosec don’t contain these dangerous chemicals.

    Valisure also found that rapid release Tylenol gelcaps dissolve far less quickly than the less costly Tylenol uncoated tablets. In this case, the problem was the misleading marketing of the product, not its risks. The manufacturer subsequently clarified that its marketing was suggesting only that the rapid-release gelcaps dissolved more quickly than other gelcaps, another reason not to trust the marketing hype on products.

    Quality and safety may be an issue because many drugs are manufactured abroad, with less stringent regulatory oversight than in the US. In 2016, the Government Accountability Office reported that nearly 1,000 of 3,000 foreign manufacturing sites had not been inspected by the FDA. Some believe that inspections alone are not enough to ensure safety.

    Here’s more from Just Care:

  • Dangerous side effects from anticholinergic drugs

    Dangerous side effects from anticholinergic drugs

    Judith Graham reports for Kaiser Health News on frequently used over-the-counter and prescription drugs that can turn a right-minded older person into someone who appears to have dementia. Beware! Drugs with anticholinergic properties can have dangerous side effects.

    One woman in her late 60’s could not answer simple questions, speak a clear sentence, or remember things that happened recently. The reason? Anticholinergic drugs she was taking.

    About 25 percent of older adults take anticholinergic drugs for allergies, leaky bladder, dizziness, asthma and psychiatric disorders, among other conditions. Specifically, the woman had been taking Benadryl for her allergies, Seroquel, an antipsychotic, and drugs for incontinence and gastrointestinal upset. All of these anticholinergic drugs keep a critical chemical messenger in the brain from operating properly.

    The woman’s Mini-Mental State Exam had suggested she had severe dementia. After her doctor recommended she go off these medicines and try others, it seemed as if she had a full recovery. But, these drugs can have long-term side effects because they may kill or weaken brain neurons.

    There is some data to suggest that anticholinergic drugs could cause dementia, though right now the data shows simply an association. Other side effects of anticholinergic drugs include: “dizziness, confusion, drowsiness, disorientation, agitation, blurry vision, dry mouth, constipation, difficulty urinating and delirium, a sudden and acute change in consciousness.” Younger people are better able to break down these drugs and therefore are less likely to have these side effects.

    Older adults should be careful about taking anticholinergic drugs. Here are some of the most common prescription drugs to beware of: Imipramine (brand name Trofanil), antihistamines such as hydroxyzine (Vistaril and Atarax), clozapine (Clozaril and FazaClo), which are antipsychotics, antispasmodics such as dicyclomine (Bentyl) and tolterodine (Detrol) prescribed for incontinence.

    These over-the-counter drugs also have anticholinergic properties: antihistamines like Benadryl and Chlor-Trimeton and sleep aids, such as Tylenol PM, Aleve PM and Nytol.

    If you are taking any of these drugs, let your doctor know. And, let your doctor know about any supplements you are taking as well; mixing these drugs with supplements could cause additional side effects. Find out the risks and the benefits. If you decide to go off these drugs, it’s important to do so slowly and work with your doctor.

    Here’s more from Just Care:

  • Opioids can kill you

    Opioids can kill you

    We all know the pleasures of a good painkiller.  We often don’t know the risks.  If we’re talking opioids, such as Vicodin, OxyContin and Percocet (hydrocodone, morphine, oxycodone and fentanyl in their generic form) those risks are huge. Opioids can kill you.

    According to Consumer Reports, every year 17,000 Americans die from opioid overdoses.  And, another 500,000 Americans end up in the emergency room.

    It’s relatively easy to become addicted to or heavily dependent on opioids. They ease short-term pain. And, doctors are prescribing them more and more.  For sure, it’s unsafe to mix them with alcohol, tranquilizers and other drugs, or to take the drugs for too long.

    A report by Express Scripts reveals that almost six out of ten patients are mixing opioids with muscle relaxants and anti-anxiety medications, a dangerous combination. The most frequent cause of accidental deaths from drug overdose stem from mixing an opioid with a benzodiazepine.

    There are other drugs such as acetaminophen, ibuprofen or naproxen to treat pain that have substantially fewer risks.  For your health, before you take an opioid, it’s important to talk to your doctor about the other drugs you’re taking, including sleeping pills. If possible, you should minimize the use of opioids.  And, of course, you should only take them as prescribed.

    Here’s more from Just Care:

  • Before ordering generic drugs from Canada or any other country, check out US prices.

    Before ordering generic drugs from Canada or any other country, check out US prices.

    If you’re one of the millions of Americans who has bought lower-cost medication from Canada or another country, then you know you often can save big time. You also know that if the pharmacy is licensed, requires your prescription, and has been verified, that you are getting the medication you ordered. But before ordering generic drugs from Canada or any other country, check out US prices.

    PharmacyChecker.com verifies international online pharmacies and compares their prices with U.S. pharmacy discounted prices. Recently, it compared prices on 34 of the most commonly prescribed generics, to determine the best savings options for Americans paying out of pocket. Out of those generic drugs, PharmacyChecker found that 88% were cheaper in the US, and by an average discount of 68%.

    For example, the price for 100 pills of lisinopril 10mg, a popular blood pressure medication, (brand name Prinivil), for which Americans filled 110,000 scripts last year from a PharmacyChecker-accredited Canadian pharmacy was $72.84. (An Indian online pharmacy charges $30.) With a free PharmacyChecker Discount Card, it’s $10 in the US.

    Amlodipine besylate is another generic blood pressure medication, one that treats hypertension to prevent heart attacks, which goes by the brand name Norvasc. For 100 pills of the 5mg generic version, the price in Canada is $40. It’s $15 in the U.S. using a free discount card.

    Of course, your Medicare Part D or other drug coverage may cost you even less than the price of low-cost generics in the US. But, if it does not, you know what you can do!!!!

    Here’s more from Just Care:

  • How safe are generic drugs?

    How safe are generic drugs?

    An op-ed by Katherine Eban in The New York Times exposes the FDA’s lax regulatory oversight of generic drug manufacturing. It makes a compelling case that generic drugs that are manufactured abroad may not be safe. What is to be done?

    The FDA is extremely limited in its ability to oversee foreign generic drug manufacturing plants.  Yet, 90 percent of the drugs we take are generic. We depend upon them heavily. And, many are manufactured abroad.

    Back in 2012, the FDA’s Peter Baker took on the job of inspecting Indian generic drug manufacturing plants.  He wanted to understand best practices. Instead, he saw serious safety risks. And, he discovered false data and reports at 29 of the 38 generic drug plants he visited. More recently, he found a similar rate of fraud and deception in Chinese drug manufacturing plants.

    Generic drug manufacturers must comply with FDA regulations, including collecting and storing data about drugs as they are made. But, they too often do not comply, according to Eban, who reports extensive problems in India and China. For example, at one manufacturing plant, Baker saw that an employee was trying to bury data showing that the manufacturer knowingly distributed insulin containing metallic pieces from a defective machine. And, it continued to use that machine to manufacture other drugs. Shortly after Baker’s discovery, the FDA stopped all imports from that plant.

    As Baker continued his inspections, he discovered that fraud and deception were the norm at these generic manufacturing plants. He identified secret labs and false data at nearly 80 percent of plants. The FDA was receiving completely trumped up reports from the manufacturers. Around 40 percent of generic drugs sold in the US are manufactured in India.

    Moreover, the FDA reports that  80 percent of active ingredients in all drugs sold in the US are not made in the US. And, 40 percent of finished drugs are imported. Gabriel Levitt, president of PharmacyChecker.com told me that his company found that 71 of the 100 most frequently used brand-name drugs are not made in the US. 

    Eban writes that “In some instances, deceptions and other practices have contributed to generic drugs with toxic impurities, unapproved ingredients and dangerous particulates reaching American patients.” And, she says that the generic drugs are, in some cases, making patients in the US sicker.

    Eban doesn’t highlight concerns with brand-name drugs, even though many of their active ingredients are manufactured overseas as well, including India and China. And, some brand-name drugs manufactured in the US have been found to put patients at risk. In 2010, the government fined Glaxo-Smith Kline $750 million for intentionally selling 20 contaminated drugs that may not have been safe or effective. More recently, the FDA cited Pfizer for manufacturing and selling EpiPens that did not work properly, which may have led to the death of seven people.

    Between 2013 and 2018, the FDA has lightened the punishment on generic drug manufacturing plants that cook their books or otherwise make drugs that may be unsafe. It often asks the manufacturer to take “voluntary action” to address problems and allows their drugs to be sold in the US.

    Eban calls on the federal government to ban drugs in the US that are made in plants that do not comply with FDA regulations. That seems like a fair start. Another strategy would be for the federal government to manufacture the drugs itself, something it once did in some instances.

    Here’s more from Just Care:

  • How to avoid harm from prescription drug overload

    How to avoid harm from prescription drug overload

    Medications can treat symptoms, prevent disease, and even extend our lives. But can taking too many drugs be harmful? A new report from the Lown Institute finds that millions of older Americans are at risk of harm from the side effects of multiple prescription drugs, an epidemic experts are calling “Medication Overload.”

    Over the past few decades, the number of medications Americans are taking has skyrocketed. Currently, 42 percent of Americans age 65 and over take five or more drugs compared to just 13 percent in the mid-1990s. Nearly 20 percent of older Americans take ten or more medications.

    Taking five or more medications should be seen as a red flag for potential harm. Each additional prescription drug increases the risk of serious side effects, such as delirium, falls, and bleeding. Last year, five million older Americans – one in ten – sought medical treatment for an adverse drug event. More than a quarter million were hospitalized. It’s very likely that you or someone you know has experienced harm from too many medications, whether it is physical harm from drug side effects or mental exhaustion from managing a laundry list of medications.

    Fortunately, patients, families, and caregivers can take steps to reduce medication overload.

    While our culture reinforces the idea that there’s “a pill for every ill,” patients, families, and caregivers can and should question that assumption. The best way to prevent harm from medication overload is to avoid taking unnecessary medications in the first place.

    Before adding another medication to your regimen, ask your doctor these questions:

    • What is this medication for?
    • How will we know when the medication is working or not working?
    • When should I stop taking this medication?
    • Can I start on a lower dose and see if that works?
    • Are there side effects I should watch out for if I take this medication?

    If you believe that you, or a family member, are experiencing harmful side effects from medication overload, or are having trouble managing too many pills, ask your primary care provider for a “prescription checkup.” This checkup is an opportunity to discuss any side effects you’re concerned about, and identify any unnecessary or potentially harmful medications you can stop or taper. If possible, bring a full list of the medications you (or your family member) are taking to the visit.

    Engaging in conversations about medications with your doctor is an essential part of reducing medication overload, but it is by no means the only solution. (For a full list of recommendations for addressing medication overload, see the Lown Institute report.) Health professionals, policymakers, and patients must come together to tackle this problem, for the sake of the health and well-being of millions of Americans.

    This post was co-written by Judith Garber, a health care policy and communications fellow at the Lown Institute and co-author with Brownlee of “Medication Overload: America’s Other Drug Problem.”

    Here’s more from Just Care: