JustCare

Category: Drugs and technology

  • Marijuana appears to offer several benefits…and risks

    Marijuana appears to offer several benefits…and risks

    Sanjay Gupta writes for CNN.com about his change of heart on the benefits of marijuana, notwithstanding its risks. In traveling the world, Gupta spoke directly to people for whom marijuana was the only treatment that offered relief. He also learned that the proportion of older adults using marijuana in the US is growing more rapidly than any other age cohort.

    Gupta is clear that marijuana is not a cure-all. But, for example, it sometimes can prevent seizures in children. Still, it does not work to offer relief to everyone. What’s worse, marijuana can contribute to falls, which often land older adults in the emergency room.

    Until 1996, cannabis was illegal in every state for all purposes. Today, marijuana is legal in 38 states as well as the District of Columbia. Some of the remaining states make it a crime to possess marijuana, even for medicinal purposes. The federal government still treats marijuana as a “Schedule 1 substance,” with no accepted medical use and a likely chance of abuse.

    Apparently, federal law notwithstanding, many older adults use marijuana daily to address sleep issues, pains, anxiety and depression. They tend to like it better than anti-depressants, opioids and sleeping pills.

    Marijuana could reduce the number of prescription drugs older adults take. Today, three in 10 older adults take at least five prescription drugs daily.

    Gupta says that our bodies actually produce cannabis and have cannabinols receptors. Our endocannabinoid system balances our body, but it weakens as we age. That’s why older adults tend to struggle more with sleep and pain and mood.

    If you are thinking that you’d like to try cannabis, Gupta suggests you start with a low dose and take it slowly. There are more than 100 cannabinols, so we don’t generally have a good idea of how any particular cannabis you take will affect you. All we know is that it could give you a very good night’s sleep.

    Here’s more from Just Care:

  • Blue Shield of California ends contract with CVS Caremark in attempt to lower drug prices

    Blue Shield of California ends contract with CVS Caremark in attempt to lower drug prices

    FierceHealthcare reports on Blue Shield of California’s decision to end its contract with CVS Caremark in an attempt to lower drug prices for its 4.8 million enrollees. CVS Caremark has been doing all price negotiation and formulary design for Blue Cross of California and pocketing a lot of the rebates and fees it collects from pharmaceutical corporations. Will Blue Shield of California’s enrollees actually see their drug costs drop?

    Going forward, Caremark will only handle specialty drugs for Blue Shield of California enrollees. Amazon Pharmacy, Abarca, Mark Cuban Cost Plus Drugs and Prime Therapeutics will also be involved in different ways in ensuring enrollees have their prescription drug needs met.

    Prime Therapeutics will take on drug price negotiation with the pharmaceutical companies. Abarca will pay pharmacists for people’s drugs. Cost Plus Drugs will develop a simple way of pricing drugs so that people are not surprised when they go to the pharmacy. Amazon will be in charge of drug deliveries and will let enrollees know upfront the cost of drugs.  

    Blue Shield of California says it would like to reduce drug costs by 10 to 15 percent. Given how much money the PBMs currently earn from negotiating drug prices and pocketing rebates and fees for themselves, that should be more than feasible in theory.

    Blue Shield of California says it wants to eliminate drug rebates and fees. But, time will tell if it simply has developed a new prescription drug model that contributes more to its revenues. Blue Shield of California could simply be transferring some profits away from CVS Caremark to itself. 

    The US spent $600 billion a year on prescription drugs in 2021. That’s $1,500 for every individual. Spending continues to rise significantly. Congress has yet to do anything meaningful to lower drug prices other than to give Medicare some negotiating power over a very small number of drugs through the Inflation Reduction Act. So, at this point, any activity that could lower drug prices is a plus.

    Here’s more from Just Care:

  • Prescription drug shortages and quality issues are a growing concern

    Prescription drug shortages and quality issues are a growing concern

    Imagine yourself in the hospital and the hospital being out of the critical chemotherapy drugs you need. That sounds like something more out of the Soviet Union than the United States, but almost every hospital in the US is facing prescription drug shortages. Prescription drug shortages are leading to drug rationing, treatment delays and, sometimes, no treatment possibility, reports Stat News.

    One new survey of 1,100 hospital pharmacists from the American Society of Health-System Pharmacists found that one in three hospitals are rationing drugs or not providing critical treatments. Virtually all hospital pharmacists report inadequate supplies of some prescription drugs. Treatments for syphilis, different cancers, severe pain are hard to come by. More than eight in ten hospital pharmacists say hospitals are rationing care or switching to alternative treatments.

    Pharmacists are forced to buy different drugs or different concentrations of drugs or getting their drugs from pharmacies that manufacture the drugs through compounding. The consequences are not only dire for some patients but causing almost three in four pharmacists to pay more for drugs. And, the situation is getting worse.

    What’s responsible for these shortages? Everything from climate issues and increased demand, to quality issues.

    The Food and Drug Administration’s response is unsatisfying. As of now, the FDA is not acting to ensure patients get treatments that are safe. It is permitting Intas Pharmaceuticals to continue to import chemotherapy treatments notwithstanding its finding of “a cascade of [quality] failures” where its drugs are manufactured. The FDA reported that an Intas analyst poured “acetic acid in a trash bin containing analytical balance strips,” in order to destroy records.

    Quality issues at plants in China and India are particularly concerning. Many generic drugs and chemotherapy ingredients are produced in these plants. What’s pretty clear is that some chemotherapy treatments are of questionable quality.

    Here’s more from Just Care:

  • Five Congressional committees seek to regulate prescription drug middlemen, without fixing the broken system

    Five Congressional committees seek to regulate prescription drug middlemen, without fixing the broken system

    For years now, Pharmacy Benefit Managers or PBMs, as they are widely known, have been profiting handsomely from negotiating drug discounts with pharmaceutical corporations and keeping much of the savings. While these prescription drug middlemen succeed at bringing down prescription drug costs, patients are still paying high prices for their drugs. Five Congressional committees now seek to regulate these PBMs, reports MedPage Today, without helping to lower drug costs in a meaningful way. The system is broken.

    You might think that bulk purchasing of pharmaceuticals would lead to steep discounts for patients. Instead. when the discounts are negotiated, they tend to go largely to PBMs and insurance companies. What’s even more problematic is that PBMs and insurers (some of which own PBMs) stock prescription drug formularies–the drugs an insurer covers–with drugs on which they earn significant revenue. Sometimes, formularies do not include generic or lower-cost alternative drugs because lower-cost drugs would cut into PBM and insurer profits.

    The PBM bills in Congress right now would not lower drug prices appreciably, if at all. They simply require PBMs to disclose some details concerning what they end up paying for drugs and how much they are paid for their work. To what end?

    Three PBMs control the vast majority of the market, which allows them to profit wildly. It’s hard to see how knowing more about what the PBMs pay for drugs or how much they earn from their work would benefit consumers. Perhaps large corporations could use the information to achieve slightly better drug prices.

    Even the Congressional Budget Office (CBO) sees precious little financial benefit from these PBM disclosures. The CBO estimates only $900 million in savings early on, diminishing over time. The PBMs profit $18 billion a year now. What would the Congressional bills do specifically?

    Bernie Sanders, who chairs the Senate Help Committee, has a PBM bill that would require more disclosure from PBMs. The bill calls for disclosure of copayment assistance by drug corporations, as well as which drugs the insurer covered, and how much insurers spend on prescription drugs. It also forbids PBMs from “spread pricing,” or requiring insurers to pay more for a drug than the PBM pays the pharmacy for the drug.

    The bill does require PBMs to give the health “plan sponsor,” aka the insurance corporation, all rebates, fees, alternative discounts, and other remuneration received from a drug manufacturer. Who benefits here is not clear.

    The Senate Finance Committee bill would require that insurers pay PBMs “a bona fide service fee,” rather than an amount tied to a drug’s price. PBMs would also need to disclose drug prices to Medicare Part D insurers and the HHS Secretary. Delinking PBM fees from the price of a drug would at least arguably disincentivize PBMs from putting expensive drugs for which they negotiate large savings on a formulary in place of generic drugs. The PBMs should have no more incentive to have higher-cost drugs on a formulary than lower-cost drugs.

    The question remains as to why our government allows insurers and PBMs to decide which drugs are on their formularies. If the government is not going to mandate which drugs are covered, an independent agency should evaluate drugs based on their price, efficacy and safety and come up with the drugs all insurers must cover. At the very least, formularies should all include low-cost generic alternatives, when available.

    Here’s more from Just Care:

  • Congress should overhaul drug patent laws to ensure Americans access to medications

    Congress should overhaul drug patent laws to ensure Americans access to medications

    Anyone who thinks that the pharmaceutical industry should continue to be able to gouge Americans with their near-monopoly pricing power should recognize that this power is preventing people from filling prescriptions and keeping important drugs from both coming into the market and from being manufactured. Mounting evidence suggests the need for the government to intervene to ensure that people get the medications they need.

    A story in The New York Times about a lawsuit against Gilead, a pharmaceutical company, for failure to bring a critical drug to market quickly, speaks volumes about how drug company profits come before patient health. The delay in bringing a new HIV drug to market allowed Gilead to maximize revenue on another drug with possibly more dire side effects.

    The people at Gilead believed the new drug would have less harsh side effects on people’s kidneys and bones. But, the drug likely would bring down revenue on Gilead’s patent-protected drug. So Gilead’s executives  decided to delay bringing the new drug to market until the patent-protected drug lost its protection. Based on a review of Gilead’s internal documents, the New York Times reports that Gilead was “gaming the U.S. patent system to protect lucrative monopolies on best-selling drugs.”

    Stories also abound about drugs that are not available because pharmaceutical companies are not able to make big profits selling them. These drugs are not outliers. They can treat cancer and heart disease and basic infections. And, there are drug shortages of more than 300 of them.

    Geoffrey Joyce, Director of Health Policy at the USC Schaeffer Center, explains in The Express that drug shortages have been around for some time. But, we are seeing shortages of more drugs of late and we are seeing drug shortages for longer time periods. Amoxicillin to treat ear infections, for example, is hard to get, as is lidocaine and albuterol, which many Americans depend on for treating their asthma. Ironically, the problem is that these drugs come with a low price tag, so pharmaceutical companies don’t see the financial value of producing them.

    Because of US patent laws, pharmaceutical companies can pretty much call the shots on what they charge for brand-name drugs for a long period of time. That means big bucks for them. They can charge many times more for these drugs in the US than in any other wealthy country because every other wealthy country negotiates drug prices. And, drug companies generally can charge high prices for at least 20 years or until their patent expires, which could be even longer. Once a drug is off patent, they face generic competition and prices tend to fall, along with profits.

    Even when drug companies outsource generic drugs for manufacture, they do so to cut costs and, in the process, sometimes undermine quality and supplies. Interestingly, though the FDA struggles to inspect foreign drug manufacturing facilities, it allows the sale of these drugs in the US but still does not allow drug importation.

    And, when several companies manufacture a generic, quality and supplies can suffer. The supplier of key ingredients might be the same for all of them. If the supplier stops producing, no generics are produced. Or, the supplier might be responsible for a harmful ingredient in all the generics. Who knows the consequences in any given situation, but people can die.

    Joyce proposes that the US produce more generic drugs, as California has proposed to do.

    Here’s more from Just Care:

  • Corporate health insurers use NaviHealth algorithms to deny care in Medicare Advantage plans

    Corporate health insurers use NaviHealth algorithms to deny care in Medicare Advantage plans

    Beware of corporate health insurers that use NaviHealth, an AI system tha can inappropriately deny care to people in Medicare Advantage plans. Former employees at NaviHealth report that its AI algorithms wrongly deny care to Medicare Advantage enrollees in serious health, reports Stat News. UnitedHealth, which owns NaviHealth, and other health insurance companies, rely on NaviHealth in their medical decisionmaking,

    Employees at NaviHealth are complaining in internal communications that insurers are denying care to people who are on IVs in rehab facilities. Medicare should cover up to 100 days in a rehab facility for eligible individuals. But, NaviHealth sometimes determines that they need to leave rehab before it is appropriate for them to do so.

    As Stat previously reported, insurance corporations use AI–computer programs–to deny care to Medicare Advantage enrollees with serious diseases and injuries. The NaviHealth system does not consider individual patient’s needs in its determinations about when to stop covering care. Patients, physicians and NaviHealth workers are “increasingly distressed” that patients are not able to get the care they need as a result of these computer algorithms.

    Former medical review employees at NaviHealth say that they were not allowed to use their independent clinical judgment to allow continued stays in rehab facilities when the NaviHealth system said to deny care; they had to follow the algorithms. “That was very different from before we were owned by Optum.”

    As Stat News reports, this is the dark side of AI. Reporters spoke with five former NaviHealth employees, patients, lawyers, experts; they also reviewed internal communications at NaviHealth. For its part, NaviHealth says its algorithms are merely a guide and NaviHealth does not make coverage decisions. But, how often do insurance company medical review staff not follow the NaviHealth “guide” when the medical evidence suggests patients still need care?

    Stat News finds that the NaviHealth algorithms are central to coverage decisions, influencing outcomes. NaviHealth likely is responsible for huge profits for UnitedHealth and other health insurance corporations. But, those profits come at the cost of people’s health and sometimes endanger their lives. Patients’ only resort when NaviHealth denies care is to pay privately for the health care services and appeal the denials. (And, that’s only if they have the means to do so.) Patients have a high likelihood of prevailing, but many of them cannot afford to pay for that care privately.

    Here’s more from Just Care:

  • Medical device corporations and physicians harm patients through artherectomies and gouge Medicare

    Medical device corporations and physicians harm patients through artherectomies and gouge Medicare

    The New York Times reports that Medicare’s outpatient payment system has led to many people receiving unnecessary and often harmful medical procedures. Medical device manufacturers receive millions of dollars from Medicare to cover the devices used to perform artherectomies, a medical procedure intended to open up blocked arteries in people’s legs. But, people can lose their legs as a result of this procedure.

    In one case, a patient had a wound on her foot and ended up having her leg amputated after 18 procedures “to improve blood flow” over a year and a half.  According to one insurance company, 45 people who received this treatment in the last four years lost a leg.

    The doctor who performed the surgeries on people with peripheral artery disease received payments from medical device companies. Peripheral artery disease leaves plaque in people’s arteries that can stop their blood from flowing. But, peripheral artery disease is usually symptom-free and does not need to be treated.

    People with peripheral artery disease can improve their conditions with exercise and blood-thinning medicines rather than surgery. It is common for them to also have heart disease or diabetes, which are risky conditions. Treatments include insertions of stents or balloons into the arteries. They also include atherectomies, which involve cutting out the plaque. But, artherectomies are risky and can lead to amputations. Even so, more people are getting these surgeries.

    Why are artherectomies more common than they should be? Money. As of 2011, Medicare pays physicians thousands of dollars for artherectomies in outpatient settings. So, medical device companies have a financial incentive to design devices physicians can use for these surgeries. Medical device companies help train physicians to use their devices, as well as how to get loans to pay for them, and how to bill for their procedures.

    Medical device companies also often reward physicians who use their medical devices when they perform artherectomies. Not surprisingly, artherectomies are costing our health care system $2 billion each year.

    Is there good evidence that artherectomies can be beneficial? Not a lot. They can inflame people’s arteries and worsen their conditions. Lifestyle changes,, such as quitting smoking and exercising are often what’s needed to treat peripheral artery disease.

    What’s the FDA’s role? The FDA tends to approve new medical devices without evidence that they are beneficial. So long as the medical device manufacturer shows that they are “similar” to other devices, the FDA approves them.

    What’s the government doing? Too little, too late. Sometimes, the government imposes small fines on physicians. In May, the Justice Department sued one physician for performing several hundred unnecessary procedures. Who knows how the suit will be resolved.

    Here’s more from Just Care:

  • Beware experimental Alzheimer’s drug trials

    Beware experimental Alzheimer’s drug trials

    Melody Peterson reports for the LA TImes on how pharmaceutical companies enlist Californians with Medicare to participate in a clinical trial for experimental drugs intended to stave off Alzheimer’s. Ads promote drug trials for people who are losing their memories, as a way to keep their minds sharp. But, participating in an experimental Alzheimer’s drug trial carries serious risks.

    The pharmaceutical companies see Alzheimer’s drugs as a mega-opportunity to generate outsized profits. The six million-person market is huge and only growing. There’s little limit on what pharmaceutical companies can charge for these drugs. And, if FDA-approved, Medicare must cover them when medically reasonable and necessary.

    Already, the FDA has approved Aduhelm and Leqembi, which costs $26,000 a year, even though neither drug shows significant benefits and both can have serious side effects. Now, the race is on for pharmaceutical companies to market other drugs. But, the pharmaceutical companies need nearly 60,000 individuals to participate in the clinical trials of the 140 drugs being developed that are still experimental. 

    No question that if an Alzheimer’s drug works well, it could improve and extend the lives of people with Alzheimer’s and, arguably, save the health care system money as well. But, the clinical trials are not designed to treat people, only to test a drug’s efficacy. In fact, the trials can severely harm people.

    Some believe the Leqembi trials were responsible for the death of three people, though the drug’s manufacturer claims Leqembi was not likely the cause of their deaths. Four in ten participants in the Aduhelm trials experienced brain bleeding or swelling.

    Do trial participants understand that these experimental drugs come with a risk of brain swelling or bleeding? Is there a financial conflict of interest for the trial investigators who could make big money from the experimental drugs when they recruit trial participants? Do they overpromise?

    One recruiter offers older adults free meals and health tips. Pharmaceutical companies pay for the costs of recruitment activities. Then, their agents get people who are interested in participating in a clinical trial to sign a long consent form.

    But, how can you expect people who are struggling with memory issues to understand the consent form? They’re likely unaware of what they are signing. For that reason, federal regulations forbid people’s enrollment in a clinical trial if they lack the mental ability to understand a consent form, unless someone who has the legal authority to consent on their behalf does so.

    But, the clinical trial recruitment team is not required to have an independent monitor overseeing recruitment activities. And, it is not in their interest financially to ensure that the people they recruit have the ability to understand a consent form. The recruiters generally receive between $40,000 and $75,000 for every person they recruit to participate in a trial.

    What’s equally concerning is that the FDA can approve a drug like Leqembi, even when, based on the findings, experts question whether its benefits are meaningful. When a pharmaceutical company invests in a clinical trial, it does not need to release information on the results. To hide the results when they do not appear favorable, the pharmaceutical company can simply stop the trial.

    Here’s more from Just Care:

  • Which outpatient drugs are costing Medicare the most?

    Which outpatient drugs are costing Medicare the most?

    In a little more than a month, we will know which ten outpatient prescription drugs will be subject to Medicare price negotiation under the Inflation Reduction Act in 2025. (That’s if the pharmaceutical companies do not prevail in their lawsuits aimed at stopping Medicare drug price negotiation.) The drugs whose prices will be negotiated will be those, covered under Medicare Part D, that are costing Medicare the most.

    In 2026, Medicare will negotiate prices for 10 additional drugs. In 2027, Medicare will negotiate prices for 15 additional Part D drugs. In 2028, Medicare will negotiate prices for yet another 15 Part D drugs.

    Beginning in 2029, Medicare will negotiate prices for 20 drugs covered under Part D and Part B, which covers inpatient drugs. Under the law, Medicare can only negotiate the prices of single-source brand-name drugs, which have been on the market for at least seven years, or biologics that do not have biosimilar options, which have been on the market for at least 11 years.

    A small number of drugs are responsible for a significant portion of Part D prescription drug spending. Medicare spent $48 billion on the ten drugs with the highest spending in 2021. Half of those drugs are treatments for diabetes: Trulicity, Januvia, Jardiance, Lantus Solostar, and Ozempic. The other half include Imbruvica, a cancer treatment and Humira Citrate-free (Cf) pen, a treatment for rheumatoid arthritis.

    Prescription drug prices are soaring, especially for the drugs that Medicare is spending the most on. In the three years between 2018 and 2021, the price of these ten drugs more than doubled. Spending jumped from $22 billion to $48 billion. Total Medicare Part D spending rose from $166 billion to $216 billion.

    Twenty-two percent of Medicare Part D spending results from just ten drugs out of a total of 3,500 (0.3 percent) that Medicare covers under Part D. Sixty-one percent of total spending results from just 100 drugs (3 percent of covered drugs).

    In 2021, Medicare spent $2.6 billion on Ozempic, to treat diabetes for 500,000 Medicare patients, $5 billion on Revlimid, to treat multiple myeloma, and $12.6 billion on Eliquis, a blood thinner.

    Not all of these drugs will be eligible for drug price negotiation: Ozempic, Revlimid, Humira and Lantus are not eligible. Ozempic has not been on the market long enough and the other three have biosimilars.

    The Congressional Budget Office estimates that, as a result of drug price negotiation, Medicare will save $100 billion on prescription drugs costs in the five years beginning in 2026. That’s a beginning, but hardly enough. If Congress would only permit prescription drug importation from verified pharmacies abroad, it would help drive down drug prices considerably.

    Here’s more from Just Care:

  • Senator Sanders wants a commitment from President Biden to lower drug prices

    Senator Sanders wants a commitment from President Biden to lower drug prices

    Senator Bernie Sanders is refusing to join with President Joe Biden and fellow Democrats to support the president’s nominee to head the National Institutes of Health. The Washington Post reports that Sanders, who heads the Senate HELP committee, first wants a commitment from President Biden to lower drug prices.

    We need “a very clear” government strategy on how to bring down prescription drug prices, says Sanders. Americans pay many times more than people in other countries for our drugs. And, not only is that insane, it is unconscionable. High drug prices are literally killing people, keeping them from taking heart and cancer medications they need to stay alive. High prices are also driving up federal health care spending.

    As chair of the Senate HELP committee, Senator Sanders decides whether to confirm nominees for positions at the Department of Health and Human Services. He hopes to pressure the administration to establish a plan for lowering drug prices. He’s gotten media attention, but will he get Biden to act?

    President Biden says he is concerned about the price of prescription drugs. He signed the Inflation Reduction Act, which allows Medicare to negotiate some drug prices. But, that’s only for people with Medicare and only covers a small number of drugs.

    A recent report from the Department of Health and Human Services found that in the year between 2021 and 2022, the price of more than 1,200 medications rose more than 31 percent. The pharmaceutical industry blames Pharmacy Benefits Managers (PBMs) for high drug prices. They are to blame, and so are pharmaceutical companies. PBMs pocket most of the savings they secure from bulk purchasing of drugs rather than using the savings to reduce drug costs appreciably. Pharmaceutical companies charge high prices.

    Senator Sanders’ team just issued a report finding that even when taxpayer dollars go to funding pharmaceutical company research that leads to the development of new drugs, Americans pay a lot more than people in other countries for those drugs. Americans pay for those drugs to be developed and are then expected to pay again in spades for them when they need them.

    Senator Sanders wants all drugs created with taxpayer dollars through the NIH to come with a “reasonable pricing clause.” He doesn’t spell out what that means. It should mean a price equal to if not lower than what any other wealthy country pays for those drugs. That’s only reasonable since we’ve paid for their development.

    The easiest way to bring down prescription drug prices quickly is to open our borders to drug importation from verified pharmacies and require insurers to cover their cost. But, no one is yet calling for that.  Sanders’ goal is to change government policy with regard to the pharmaceutical industry and demand that prescription drug costs in the US drop considerably. Good luck!

    Here’s more from Just Care: