Category: Drugs and technology

  • Internists urge government to negotiate drug prices

    Internists urge government to negotiate drug prices

    The American College of Physicians, a trade association of doctors in internal medicine, joins the majority of the public, along with a growing chorus of doctors and other influentials in calling for the federal government to negotiate drug prices. In a paper published last month in the Annals of Internal Medicine, they say they are representing their patients struggling to afford needed drugs.  And, they believe Congress should regulate the price of drugs just as every other developed country does.

    Inexplicably, the American College of Physicians, the “ACP,” stops short of urging Congress to negotiate drug prices for everyone in the nation.Seven out of 10 Americans take at least one prescription drug. Every other member country of the 34-member Organization for Economic Co-operation and Development (OECD) reins in prices for everyone, not just older adults and people with disabilities.

    The ACP does call for allowing Americans to reimport certain drugs from Canada and other countries that regulate drug prices, provided they are deemed safe. The ACP further recommends that policymakers should take heed of how pharmaceutical companies price their drugs. Pharmaceutical companies should be transparent about their costs, particularly for drugs developed with government funding through the National Institutes of Health and the Veterans Administration.

    We should also understand the comparative value of different drugs. Policymakers should assess the cost, pricing and value of prescription drugs.

    It’s not clear what it will take to get Congress to pass legislation to regulate drug prices or allow drug reimportation. Members and their staff routinely leave Congress to work for the drug industry. And, many have a financial stake in the drug companies. Republicans and some Democrats in Congress appear to have no problem using their power to allow drug companies to gouge consumers and prevent them from getting needed care.

    Here’s more from Just Care on drug prices:

  • Medicare Part D drug costs rising

    Medicare Part D drug costs rising

    The private Medicare plan bait and switch continues. It wasn’t that long ago that copays in private plans were reasonable, affordable even, without Medicare supplemental insurance to pick up the cost. This year, Medicare Part D drug plans have moved from fixed copays to coinsurance, a percentage of the cost, for the majority of drugs they cover.  Consequently, out-of-pocket prescription drug costs are projected to rise again for people with Medicare.

    The advantage of traditional Medicare, beyond the wide choice of doctors and hospitals it offers anywhere in the country and easy access to care, has always been that it allows people to budget for their health care.  With supplemental insurance, there are few if any out-of-pocket costs. And, while supplemental coverage can be costly, knowing health care costs for the year gives people peace of mind.

    But, until Congress allows CMS to negotiate drug prices instead of permitting drug companies to charge astronomical prices, drug costs will continue to escalate for everyone.  For now, Congress has chosen to penalize the public and reward the drug industry since insurers have limited if any ability to rein in drug prices. To keep premiums down, they simply shift more costs to their members.

    The share of Medicare Part D drugs with coinsurance payments has been growing steadily in the last few years. According to Avalere Health, 58 percent of covered drugs in Part D plans now have a coinsurance payment. In 2014, about one in three drugs in Part D plans (35 percent) had coinsurance payments. Last year it was 45 percent.

    The Medicare Advantage plans are also shifting increasingly to coinsurance payments for certain drugs. This year 26 percent of their drugs have coinsurance payments.  You can expect that to increase.

    Here’s more from Just Care on prescription drugs:

  • Bitter pills: Once popular drugs pulled from the market

    Bitter pills: Once popular drugs pulled from the market

    Nearly 5 billion dollars.

    That’s how much pharmaceutical company Merck paid to people and families who claimed the painkiller Vioxx harmed them or their loved ones. In one of the largest civil lawsuit settlements in recent history, the Vioxx manufacturer in 2007 agreed to pay $4.85 billion to people involved in the 27,000 outstanding Vioxx lawsuits against Merck. Those cases claimed that Vioxx was linked to stroke, heart attack or premature death. But while the company agreed to settle, it never admitted the drug was at fault.

    Many drugs that come on the market with promise are advertised to the hilt and taken by thousands or millions of people around the world — and then either quietly (or with a big splash, as with Vioxx) disappear. Why? Here are four reasons:

    1. Clinical trials aren’t as big as you think, explains drug safety expert Glen Schumock, PharmD, the head of the department of pharmacy systems, outcomes and policy at the College of Pharmacy at the University of Illinois, Chicago. Some may enroll as few as 1,000 people, and while all side effects are noted, some are uncommon. “Say there’s an adverse effect in 10 out of 100,000 people, but if you only have 6,000 people in your trial, you might not see that side effect because the frequency is so rare,” says Schumock. Consider, though, when that drug is given to 1,000,000 people — that means 10,000 people will have that “rare” side effect. (See our blog, “Do Rare Side Effects Happen?”)

    2.”Real world” use of a drug differs, sometimes dramatically, from what goes on in a clinical trial. People selected to take part in a trial “typically have to meet some kind of criteria that is designed to give the drug the best chance to work,” says Schumock. Trial subjects may not be as sick as the average patient, are not taking other medications, and don’t have other diseases. Such participants are also highly monitored, typically seeing a medical professional every couple of weeks. Clinical trials are controlled environments. The real world, well, isn’t.

    3. Time plays a role. Once a medication is approved by the FDA, patients and physicians may discover negative food or other drug interactions that didn’t occur during the trial’s timeline.

    4. Off-label prescribing may bring up unexpected issues. A drug may be approved for one condition or population, but physicians are free to prescribe it for other uses or people, including children or the elderly, says Schumock. This can be problematic: children can be more sensitive to a drug’s side effects; the elderly, who may be more likely to have kidney function problems, might be exposed to more toxicity because the drug leaves the body at a slower rate.

    All this helps explain why some drugs might get pulled from the market — either thanks to legal or regulatory pressure, or voluntarily on the part of the manufacturer — but you may not always hear that a drug is no more.

    This post is excerpted from Medshadow. To read more about drugs that have been pulled from the market, click here.

  • Cognitive behavorial therapy through telemedicine can reduce anxiety

    Cognitive behavorial therapy through telemedicine can reduce anxiety

    Older adults often suffer from anxiety disorder but lack access to treatment.  A recent study published in JAMA looked at cognitive behavioral therapy through telemedicine as a means of helping older adults to recognize anxiety symptoms and to cope.  At the end of four months, both the researchers and the participants saw a reduction in the severity of worry, generalized anxiety disorder and depressive symptoms among participants..

    The study involved 141 participants, 70 of whom received the cognitive behavioral therapy by phone and 71 of whom received unfocused supportive therapy by phone.

    Of note, Medicare now sometimes pays for telemedicine or telehealth services, but only for people in some rural areas and not from their home; it is also finding ways to pay for house calls.

    Here’s more information from Just Care about Medicare-covered services:

  • Scientists spin artificial blood vessels in cotton candy machine

    Scientists spin artificial blood vessels in cotton candy machine

    It’s hard to imagine but scientists can spin artificial blood vessels in a cotton candy machine. And, that’s just the beginning. Like 3-D printing, eventually, it could be a way to create artificial organs, including livers and kidneys, and even bones.

    According to Vanderbilt News, researchers are using a $40 machine to manufacture create thin fibrous tissue like cotton candy, which they can turn into artificial blood vessels. After spinning the tissue, they pour gelatin over it.  They then dissolve the cotton candy like tissue from the resulting “hydrogel”. What remains are artificial tiny blood vessels that can substitute for heart muscle, among other body tissues.

    So that the blood vessels behave like capillaries, the researchers line the blood vessels with moist human cells that are held together by an enzyme. And, much like capillaries, the network of artificial blood vessels are then channels that permit oxygen and nutrients to flow to and from them. Watch here:

    If you’re interested in learning about other cool health tech innovations, we have a lot to share with you:

     

  • Do Prilosec and other PPIs increase people’s risk of dementia?

    Do Prilosec and other PPIs increase people’s risk of dementia?

    Millions of people take proton pump inhibitor drugs (PPIs) such as omeprazole (Prilosec), esomeprazole (Nexium), and lansoprazole (Prevacid) for heartburn or gastro-esophageal reflux disease (GERD). This week, news outlets reported a link between these drugs, which many people stay on for years or even decades, and the risk of dementia.

    Researchers in Germany examined an insurance claims database that included over 73,000 people, 75 and older, and free of dementia at the study’s start. They found that over seven years those who took PPIs had a 44% increased probability of receiving a diagnosis of dementia.

    Since this finding comes from an observational study, and not a clinical trial, the researchers can’t say whether the drugs actually cause dementia, although they discuss some plausible reasons why they may.

    Nothing is known about long-term side effects of drugs when they are approved by the FDA. (See this Just Care post about FDA-approved cancer drugs that don’t work.) So, observational studies are an important way to gather this information.

    This is the second study indicating that PPIs may contribute to dementia risk. More evidence needs to accumulate though, such as showing that those who take higher doses have a higher probability of dementia, before a more definitive causal link can be established.

    For those interested in a more in-depth discussion of the findings, click here.

    To learn about ways to avoid heartburn or GERD without drugs, see this Just Care post.

    To understand the signs of dementia, see this Just Care post. To learn about safety at home for people with dementia, see this Just Care post. And, for some tips on the benefits of early diagnosis of dementia, click here.

  • Spying on cancer

    Spying on cancer

    What if a new technology could detect aggressive cancer cells, effectively spying on cancer? Researchers think it could improve the chances of treating these cancers.

    Some cancers are aggressive and fast-growing, requiring equally aggressive treatment. Most cancer deaths are caused by cancer that’s metastasized, or spread from the original location to enter the bloodstream and pop up in other, cancer friendly locations. Others are what H. Gilbert Welch calls “turtles”: slow moving and maybe not needing painful and debilitating treatment right away.

    We are on the cusp of being able to “spy” on cancer cells and actually see how they break off from a tumor and enter the bloodstream. And, that’s great news for people with aggressive cancers. Here is a video released by the NCI (National Cancer Institute) that shows, in live time, breast cancer cells breaking from the tumor and entering the bloodstream.

    https://www.youtube.com/watch?v=IvyJKrx5Xmw

    This article was originally posted on Medshadow.org. To read the rest of this article, visit the Medshadow Foundation.

    To read about high-tech goggles that allow people to see cancer cells, click here.

  • FDA backlog keeps generics from coming to market

    FDA backlog keeps generics from coming to market

    In October 2015, there were as many as 3,000 generic drugs waiting to be approved by the Food and Drug Administration. FDA underfunding may explain it in part. So might incomplete information on applications by their manufacturers as the FDA claims. But, whatever the reason, the result is that we end up paying high drug prices, (though some generic drug prices are sky high.)

    Generics can cost as little as 20 percent of what brand-name drugs cost; they can also cost a lot more.  Around 8 out of 10 prescriptions are for generic drugs but they account for less than 30 percent of our drug spending.

    The 2012 Generic Drug User Fee Amendments now require drug makers to help offset the cost of FDA review. In exchange, the FDA is supposed to speed up approval of these applications.  And, the FDA says it has. However, it also says that the application process is often slowed down because of faulty applications, which may fail to address negative side effects of inactive ingredients or other important information.

    Here are four things you may not know about generic drugs and, if you’re interested, a short primer on how federal policy promotes high drug prices.

  • Opioid deaths on the rise

    Opioid deaths on the rise

    A new report from the Centers for Disease Control (CDC) warns of the dangers of opioids.  Last year opioid pain relievers and heroin alone were responsible for some 47,000 deaths in the United States in 2014.  All told, between 2000 and 2014, almost 500,000 people died from drug overdoses. In 2014, 60 percent of these overdoses involved opioids. (Click here for Dr. Salomeh Keyhani’s post on how opioids can kill you.)

    The opioid problem appears to be growing. The CDC found a 14 percent increase in deaths from opioids between 2013 and 2014. Overdose deaths from opioids have tripled in the past 20 years. The number of deaths from opioids now compare with deaths from auto accidents and guns.

    There was a 9 percent increase in deaths from oxycodone and hydrocodone, the two opioids most involved in overdose deaths, between 2013 and 2014.  And, there was a 26 percent increase in deaths from heroin in that same period, totaling 10,574.

    A new Medscape survey shows that the majority of doctors (74 percent) are very concerned. The vast majority of doctors spend time with patients explaining proper use of opioids, but far fewer spend time on how to store and dispose of them safely.

    WebMD reported a major rise in opioid prescriptions between 1991 and 2011, from 76 million to over 219 million a year.

    Overdose deaths are up for both men and women of all ages, including blacks and whites. Five states with the highest drug overdose rates were New Mexico, New Hampshire, West Virginia, Kentucky and Ohio.

    The CDC recommends doctors prescribe smaller quantities of opioids for a short term to treat acute short-lived pain. For long-term pain, it recommends that doctors first prescribe other less addictive drugs than opioids and, only if these drugs don’t work to relieve pain, begin prescribing the lowest dose of opioids so long as risks do not outweigh benefits.

  • Will your health plan cover the drugs you need?

    Will your health plan cover the drugs you need?

    Health plans often make it hard for people to know which drugs they cover before they sign up for the plan and even harder to find out what out-of-pocket costs will be for a particular drug. Yet, different drugs in a particular class may work better or worse for a particular person.

    If you have Medicare, you should be able to find out online quite quickly whether a Part D prescription drug plan covers the anti-depressant you need.  But, a new Urban Institute study suggests that people in the health insurance exchanges may have difficulty knowing whether a health plan meets their drug needs.  

    The study looked at health plan coverage of anti-depressants in five state health exchanges and found significant differences among them in drugs covered and willingness to disclose which drugs were covered. Antidepressants are the third most commonly used prescription drug. More than one in 10 Americans over 12 take them.

    Out of 35 health plans studied, nine excluded more than five antidepressants from coverage and some excluded up to 15.  

    Allowing the plans to list drugs they cover in whatever way they choose can make it extremely hard for people to determine whether a drug is covered. And, even when people can see a drug they take is covered, it can be hard for them to know what their out-of-pocket costs will be in advance of enrolling in a plan. People in plans that charge co-insurance for drugs are generally left in the dark.

    The study recommends that the state exchanges offer direct links to easily searchable lists for each plan, make it easier for an individual to appeal the non-coverage of a drug, and monitor the process to ensure its fairness; it also recommends that out-of-pocket costs be predictable.