JustCare

Tag: Side effects

  • Pharma opera? Drug promotion on TV shows

    Pharma opera? Drug promotion on TV shows

    In the category of “what will pharmaceutical companies think of next to market their high-priced drugs,” the answer could be drug promotion on TV shows. Once dubbed soap operas because soap companies supported these afternoon TV series, they might be called Pharma operas today.

    Julia Belluz reports for Vox News that one company’s drug that treats a rare cancer appeared on General Hospital. We assume it paid for the product placement. Its marketing value is greater than an ad because TV viewers have no clue whether Pharma is behind the drug promotion and do not get a good sense of its side effects.

    As Vinay Prasad and Sham Mailankody explain in this JAMA opinion piece, unlike with TV ads where the FDA requires warnings of side effects, there is no such requirement for TV shows, where the product promotion is considered “disease awareness.”

    In the General Hospital show, one of the leading characters is diagnosed with a rare cancer, affecting just 2 in 100,000 people. No surprise, there is only one drug to treat this condition, and it costs a fortune. Prasad and Mailankody question the value of permitting “education” about this very rare cancer and its treatment.

    In their JAMA piece, they explain that direct-to-consumer advertising, which only the U.S. and New Zealand permit, has no proven public health benefit. Moreover, direct-to-consumer advertising has “suggestive evidence of harm.” It can lead to an increase in people being tested and misdiagnosed for the disease the drug treats and more people taking a toxic drug they don’t need.

    Prasad further explains that over-diagnosis can happen because there generally isn’t one test to determine whether a person has the disease, and many healthy people could be deemed to have an indication for the disease, even when they don’t have the disease. If they end up being treated, on top of the cost, the side effects can be serious, including severe anemia, enhanced likelihood of TB and viral infections.

    Here’s more from Just Care:

  • New leukemia drug will cost $475,000

    New leukemia drug will cost $475,000

    The cost of cancer care now averages over $100,000. That’s more than twice the cost of cancer treatment a decade ago. Still, pharmaceutical companies are prepared to test their monopoly pricing power further with new breakthrough drugs. Stat News reports that a new leukemia drug, just approved, will cost $475,000.

    Some assert that the new drug from Novartis, CTL019, could be worth its high price, at $475,000. But, at that price, it’s likely that most people who need it will not be able to benefit from it. As Kaiser Health News reports, in the words of David Mitchell, founder of Patients for Affordable Drugs, “drugs don’t work if patients can’t afford them.”

    CTL109 is a CAR T-cell therapy. This new drug class harvests the patient’s immune cells and then genetically alters them to kill the cancer. In CAR-T cell therapy tests, more than eight in 10 people with leukemia, for whom chemotherapy and bone-marrow transplants have not worked, have gone into remission.

    The cost for CAR T-cell therapies is on top of the cost of hospitalization and traditional chemotherapy, which patients must receive in order to increase the chances of the CAR T-cell therapies working. And, as with many recently approved drugs, the side effects could be serious. One drug company stopped developing one of its CAR T-cell therapies after five patients died from complications associated with the therapies.

    If Congress doesn’t intervene on the price of this drug (which it is unlikely to do), it could mean higher insurance premiums and health care costs for everyone. Medicare is required to cover all drugs on health plans’ formularies and is forbidden from negotiating prices. That said, the Centers for Medicare and Medicaid Services just issued a press release indicating that it is working with stakeholders on innovative pricing models for the drug, including a value-based pricing model, whatever that means.

    Novartis reports that it is working with CMS to charge Medicare for the drug only if patients respond to the CAR T-cell treatment within a month. But, Vinay Prasad, an oncologist and health research at Oregon Health Sciences University, told Politico that one month is too soon to assess the drug’s value. Patients might relapse after a year or two.

    If you believe it’s time for Congress to rein in drug prices, please sign this petition.

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  • Rheumatoid arthritis drug has dangerous side effects

    Rheumatoid arthritis drug has dangerous side effects

    If you think drugs approved by the FDA can’t kill you, think again. A recent article in Stat News explains that Actemra, a rheumatoid arthritis drug, has dangerous side effects, possibly killing hundreds of patients who took it. But, the FDA warning label made no mention of its risks of stroke, heart and lung disease, or pancreatitis. And, the FDA seems to be incapable of determining the drug’s safety or of acting to warn patients now that the drug shows signs of having dangerous side effects.

    Somehow Actemra’s manufacturer, Genentech, a subsidiary of Roche, was able to persuade the FDA that, unlike other treatments for rheumatoid arthritis, Actemra did not have serious side effects. As it turns out, just like other drugs for rheumatoid arthritis, the data suggests that Actemra can cause stroke, heart disease, heart attack, lung disease and pancreatitis.

    In fact Stat, which studied more than 500,000 reports of Actemra’s side effects, found that patients taking Actemra may be more likely to suffer a heart attack or a stroke than patients taking a competitor drug. Stat further reports that the FDA has been notified of 1,128 people taking Actemra who subsequently died.

    The FDA doesn’t have the capability to determine whether Actemra was the cause of death, and the FDA is not responsible for determining the accuracy of Actemra’s side effects, as reported by Genentech. But, Stat learned through a Freedom of Information Act (FOIA) request that several doctors ascribe their patients’ deaths to Actemra. Experts Stat enlisted to review the FOIA information say that the evidence suggests that the Actemra warning should include risk of heart failure and pancreatitis.

    Stat quotes oncologist and medical ethicist Vinay Prasad, Oregon Science University: “We’ve done a very good job of making it easier to approve drugs, often based on very preliminary evidence. But we haven’t ramped up the standards of post-marketing surveillance to make sure that what’s been out there for several years is safe and effective.” Prasad continues: “The system is broken, and all the financial incentives are lined up to keep it broken.”

    Psychiatrist, Jean Roiphe M.D., says: “It is safest to assume, until proven otherwise, that a new drug, from a given class of medication, is likely to have similar side effects and risks as other members of its class, even if there is no specific warning to that effect. Before deciding to take a newly approved drug, I recommend that patients consider taking a drug that has been around for a longer period of time, whose side effects are more well known.”

    About 1.5 million Americans have rheumatoid arthritis. It causes swelling of the joints and, sometimes, physical disabilities. It can be extremely painful. (Click here for a post on managing arthritis pain.) There is no cure for the disease, but there are several types of treatments, including therapy and a range of medications.

    You can watch Mike Papantonio, a trial lawyer, describe the dangerous side effects of Actemra here.

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  • DailyMed: Know the potential harms of your prescriptions

    DailyMed: Know the potential harms of your prescriptions

    Most of us take the prescription drugs our doctors prescribe without giving them a second thought. But, many, if not most of brand-name drugs we take, may have harmful side effects in addition to potential benefits. Might a website called DailyMed help you understand the potential harms of your prescriptions?

    DailyMed is an FDA web site, overseen by the National Library of Medicine,  which provides a wide range of information about virtually all prescription drugs, including their possible harmful side effects. You can also learn about any possible dangers from drug interactions.

    The information on DailyMed is essentially what’s written on the official FDA-approved labels for the drugs, although kept in one place and continually updated. You can check the warnings for the generic and brand-name drugs you’re taking and the risks of harmful drug interactions. But, what you’ll find is a laundry list of information.

    Unless you have medical training to weigh what is important and what is not, as literally everything associated with a drug is contained in the label, it will be hard to understand potential harms of a drug. Just because something is “associated” with a drug being taken by a sick person does not mean that drug “caused” the problem. This information is included for many reasons, including legal coverage for the drug’s manufacturer.

    There is a huge amount of information on the site, which you may want to discuss with your doctor. The site does not appear to have any consumer-friendly parts to it. Even if you were told about a drug’s risks at one time, if the drug has only been on the market 10 or 15 years, new information is always emerging. It is fairly common for the FDA to put out stronger warnings about a drug once it has been on the market for a while or to withdraw it from the market because it has been found to be dangerous. And, your doctor may not be aware.

    The DailyMed site contains 95,791 drug listings. You can search by drug name, manufacturer name, or drug class, as well as National Drug Code (NDC ) code, something you can find on a drug’s packaging from each manufacturer.

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  • Seven questions for women to ask about meds

    Seven questions for women to ask about meds

    Each year, an estimated 4 million Americans rush to the doctor or the ER in response to an adverse reaction to a prescription drug. So while medications can save or improve your life, they also cause side effects and need to be taken judiciously.

    Women should weigh the risks and benefits of each drug.

    1. What is the lowest effective dose?
    2. Can this cause dependency or a rebound effect?
    3. What is the shortest amount of time I need to be on this drug and do I have to wean myself off of it?
    4. What are the potential side effects, such as weight gain, low libido, liver or kidney problems?
    5. What if I’m planning to get pregnant or have an unplanned pregnancy?
    6. Will alcohol or other meds exaggerate or block this med’s effect?
    7. Should I make lifestyle changes or consider alternative therapies?

    When a medicine is needed, the benefits are obvious and can even be life-saving. With every medicine comes side effects, however. Here are some particular side effects associated with drugs commonly used by women.

    Birth Control/Oral Contraceptives: Pills, patch, ring, injection: Ask about weight gain, moodiness, breast tenderness, swelling, dizziness and the risk of blood clots. Birth control can alleviate PMS symptoms, prevent acne, and reduce cramping and menstrual pain. Newer methods use 3rd and 4th generation hormones, which can have a slightly higher risk of pulmonary embolism and deep vein thrombosis. Ask about the symptoms.

    Sleep Aids: Drugs in this category can cause drowsiness in the morning, difficulty waking up, mental impairment, headache, dizziness and nausea. There is often a rebound effect, meaning the symptoms can worsen when you stop the medicine. You may need to stop this drug in increments; many people find it difficult to return to a normal sleep pattern.

    GERD/Indigestion/Acid Reflux Drugs: Many of the drugs in this category block the ab-
    sorption of vitamins and calcium. There is often a rebound effect, meaning the symptoms can worsen when you stop the medicine. Ask about anemia, bone density and if vitamin supplements are needed.

    Antidepressants/Anti-anxiety Medication: It’s best to work closely with a psychiatrist and include talk therapy. Ask about weight gain, tremors, constipation, sweating and low libido. Stopping these meds can prove difficult and should be conducted under a doctor’s care.

    ADHD Drugs: Stimulants are commonly used to address ADHD. These can trigger cardiovascular issues, appetite loss, restlessness and aggression. Studies indicate that stimulant use in adolescents, whose brains are still developing, might affect their prefrontal cortex and brain plasticity (ability to switch between functions).

    This post originally appeared on the Medshadow Foundation site. For more information from the Medshadow Foundation, click here.

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  • Has osteoporosis been mistreated?

    Has osteoporosis been mistreated?

    Osteoporosis drugs strengthened the bones of millions of women. But their future may not be so bright. Here’s what we know about their long-term effects.

    Since the mid-90s, when Fosamax (alendronate) was first approved, bisphosphonates have been commonly used to effectively treat osteoporosis in millions of patients. 

    But bisphosphonates (the class of drugs that work to rebuild and strengthen bone tissue), which are taken either orally or as injections, are not without side effects and recently, some of the potential long-term effects of these medications, while rare, have come under scrutiny. Conversations about what those effects might or might not be and who, in fact, should be taking these drugs have been taking place in the media and medical community alike.

    One issue is that no one really knows yet the optimum length of time patients should be taking these drugs. A study by the FDA, published in the New England Journal of Medicine, caused a stir — taking on the question of whether or not continued use of bisphosphonates helps patients or might put them at increased risk for atypical fractures or other side effects.

    ‘In other therapies we are confident in saying the effects of the medicine are gone, once we stop giving them… Whereas with bone the exact opposite is true.’ — Kurt Kennel, MD

    The study suggests that taking bisphosphonates beyond 5 years doesn’t necessarily continue to improve bone density or strength for all patients. One recommendation is that patients who were initially at low-risk for osteoporosis-related fractures would probably benefit from discontinuing the medication after 3 to 5 years, whereas those patients at a greater risk from the outset would benefit from continuing.

    To read the rest of this article from the Medshadow Foundation, click here.

    To learn about the latest findings on proton-pump inhibitors, click here.  And, here are five ways to avoid heartburn without drugs.

    If you have Medicare, here are six ways to save money on your drugs.

  • Side effects of drugs prescribed off-label often serious

    Side effects of drugs prescribed off-label often serious

    The Supreme Court is about to consider whether drug companies should be allowed to promote their drugs for off-label use as a matter of free speech. A new study in JAMA of drugs prescribed off-label suggests that it would be a grave mistake. The researchers find serious risks from off-label use of drugs in many instances.

    The research suggests that doctors who prescribe drugs off-label do so with greater care and monitor the effects on their patients. The researchers found that only 20 percent of the time that off-label drugs were prescribed was there strong evidence to support the prescription.

    Data reveals that doctors often do not understand the indications for which the FDA has approved a drug’s use.  So, patients should ask their doctors about these indications before opting to take a drug prescribed for off-label use. At the very least there should be strong evidence of the drug’s efficacy for its prescribed use.

    To undertake the study, the researchers looked at electronic data for more than 45,000 Canadian patients over five years, including drugs prescribed, the reason the drug was taken and treatment outcomes—all of which is not available for patients in the United States.

    Of the patients studied, 7.6 percent had bad side effects. Side effects were far greater–44 percent higher–for patients taking drugs off-label than for patients taking drugs for their approved use. The researchers did not find a difference in side effects between drugs used off-label and on-label when there was strong scientific evidence to support the off-label use.

    What’s clear from the study is that we need to know a lot more about prescription drug use in the United States, both on-label off-label. We currently do not capture the reasons for which drugs are being prescribed and the outcomes for patients using the drugs.  Today, it is conservatively estimated that 11.8 percent of drugs prescribed are for off-label use.

    The FDA approves drugs only for particular use at a particular dosage, often based on clinical tests, checking for safety and efficacy.  Sometimes, these approvals are based on laboratory evidence, where the data is less compelling and the safety and efficacy of the drugs less clear. Either way, the FDA dedicates few resources to monitoring drugs post approval. Although drug companies generally are not allowed to market them for off-label use, doctors may prescribe drugs for any reason they choose.