Thursday, January 31, 2019

How safe is that object inside my body?

Medical devices, which range from heart valves to prosthetic joints to insulin pumps, are a huge business, estimated at $400 billion world-wide in 2018. As the elderly population grows, this market will only expand. A major problem world-wide is that the safety and reliability of these devices is not always guaranteed. In the United States there is a fairly robust system for approving new drugs for marketing that grew in large part out of the thalidomide disaster. Thalidomide was marketed in the late 1950s and early 1960s for morning sickness in pregnant women, and resulted in the birth of thousands of babies with major birth defects. Stiff new regulations followed, and pharmaceutical manufacturers are now expected to show both efficacy and safety of their products before they can be sold. As regular readers of these posts or Prescription for Bankruptcy know, I am concerned that in too many cases the medical experts helping evaluate new drugs are beholden to the pharmaceutical industry, but the system generally does work to maximize the cost/benefit ratio of new drugs that come to market. Drug firms must usually perform three trials of their product before it is approved.
The system for approving devices is much looser. There is often only a single trial, and these are rarely if ever randomized or blinded as drug trials are expected to be. In many cases a new device is approved based on it being similar to an existing device. Regulators routinely allow device manufacturers to make major changes to existing products without any formal evaluation.
This loose approach to regulation has resulted in a few but serious problems. The most obvious is the metal-on-metal hip prostheses, which resulted in an unacceptably high failure rate and in some cases led to metallic ions or particles being released into the bloodstream. Johnson and Johnson pulled one of their hip replacement products from the market in 2010 and Smith and Nephew pulled one of theirs in 2012. The lawyers are still having a field day. Essure, a coil-shaped metal device intended to provide permanent birth control, was implanted in the fallopian tubes of over 1,000,000 women. Even though it was designed and sold as a lifetime permanent solution, it was approved for marketing after only short-term (1-2 year) studies with very limited data (25%) going out even as far as two years. Though it seemed safe and successful in the small early studies, thousands of women suffered major complications, including severe bleeding and ruptured tubes. The manufacturer, Bayer, wrote to European doctors in 2017 asking them to stop using the product, but kept selling it in the United States; it was finally taken off the U.S. market at the end of 2018 “for business reasons.” Medtronic marketed an updated version of the wire (Sprint Fidelis) used to connect the control unit to its implantable heart defibrillator in 2004, and it was only pulled from the market 3 years later when a cardiologist published a study showing that it was failing at a much higher rate than other similar products and was either not working when needed or shocking patients (quite painfully!) when the shock was not needed.
The FDA was aware of these problems in its system but was slow to act. An Institute of Medicine panel in 2011 recommended that the FDA replace its flawed approval system that did not really establish either efficacy or safety before marketing. At the time, the FDA disagreed with this recommendation and did nothing. Only when an international group of investigative journalists published a scathing review of the medical device industry in late 2018 did the FDA finally announce that it was going to adopt new measures, and many of these will not take effect for years.
Let me be clear about one important fact. The vast majority of medical devices are both effective and safe. My two hip replacements have allowed me to remain physically active. Properly chosen heart failure patients live longer with an implanted defibrillator. However, despite the fact that most of us are law-abiding, we still need a police force. Even though most devices are safe and effective, we need meaningful oversight. If your prescription medicine proves harmful, you can stop taking it. If a device implanted in your body is harmful, you can either live with it and hope or have an invasive procedure to remove or change it. The FDA must place patients’ interests over manufacturers’ profits.

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Monday, January 28, 2019

An aspirin a day keeps which doctor away?

Should you take low dose aspirin every day? If you have coronary disease and have not had major bleeding issues, you can stop reading and look for a funny cat video. The easy answer is yes. The rest of you can read on.
Aspirin, or at least its forefathers, has been around forever. The ancient Egyptians used willow bark for aches and pains and Hippocrates prescribed willow leaves and bark for fever and pain. The active ingredient in the willow was salicylic acid, isolated by a French pharmacist in 1829. The aspirin we know, acetylsalicylic acid, was developed by Bayer Pharmaceuticals in the late 1890’s in Germany and was widely available over the counter beginning about 1915.
While aspirin has many actions, the one of most importance to its use for cardiovascular disease is its ability to prevent platelets from sticking together. Platelets are small circulating cells that plug up holes in blood vessels and prevent us from bleeding excessively. Platelets that clump together can block small arteries and are a major culprit in causing heart attacks and strokes. Logically, then, you would expect aspirin taken regularly to reduce the risk of heart attacks and strokes and increase the risk of bleeding, and this is a situation in which what seems logical is also true.
One of the first large-scale trials on which we now depend to inform medical decision-making looked at adding aspirin to the medications given patients presenting to hospitals with suspected heart attacks. This trial, called ISIS-2 was reported back in 1988 and showed that aspirin did reduce the rate of death and vascular complications when given over the short-term, and that it seemed to have few serious side effects given this way. Over the subsequent decades, numerous trials of aspirin use in patients with a variety of forms of heart disease were conducted, and the “big picture” showed that daily use of low-dose aspirin in coronary patients cut the rate of death, heart attack and stroke combined by about 22% relative to non-use. In absolute terms, if 1000 patients took aspirin and 1000 did not, the aspirin users suffered 25 fewer major cardiovascular events – at a cost of 4 major bleeding events.
What about preventing heart attacks in patients without known coronary disease? Here the benefits would be expected to be smaller, but would apply to many more people. Numerous trials have been done, and a recent review published in JAMA in January 2019 summarized the available data, looking at 13 trials that included over 164,000 participants. The bottom line was that daily aspirin use reduced the rate of major cardiovascular events from 61.4 per 10,000 person-years to 57.1 – a modest but statistically valid reduction. The price paid was an increase in major bleeding events from 16.4 per 10,000 person-years to 23.1. So, for every heart attack or stroke prevented there were almost two major bleeds.
I should note that there is tantalizing but not conclusive evidence that daily aspirin use reduces the risk of some cancers, notably colon cancer, when taken over many years. The cancers that do develop in aspirin users may be more aggressive, and there is as yet no data on overall life extension by aspirin.
Bottom line: personalize. If you have risk factors for coronary disease and no history of ulcers or other bleeding issues, I would seriously consider taking low dose aspirin daily. If your coronary risk is low, it is probably not a good idea. As the TV commercials always say, talk to your doctor.

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Thursday, January 24, 2019

To D or not to D, that is the question

Vitamin D is critically important for healthy bones. Infants and children deficient in D develop rickets and adults get weaker bones – either osteoporosis or osteomalacia. The vitamin also plays other important roles in the body, including strengthening our immune systems. Where do we get this key vitamin? The major source is vitamin D produced in our own bodies by the sun acting on our skin – about 20-25 minutes of daily sun exposure gives most of us an adequate supply, though the elderly and dark-skinned people need more. Most foods do not have a lot of D except for fatty fish. The NIH recommends that for children over 1 and adults up to 70, 15 micrograms (equivalent to 600 IU) daily is required. They suggest a higher dose (20 mcg/800 IU) daily in adults over 70. You can get this amount from 3-4 ounces of salmon, swordfish or trout. In the U.S. and Canada, all milk is fortified with vitamin D, and a cup of milk contains about 3 mcg. Many other foods including orange juice and cereals are also fortified – look at the label.
What about supplements? If you look in the pharmacy, you will find enormous shelf space devoted to vitamin D capsules, in sizes varying from 400 IU to 4000 IU or more. Do you need this? According to Boston University endocrinologist Michael Holick, absolutely. His enthusiasm for testing vitamin D levels in the blood and taking supplements, sunbathing and using tanning beds is boundless. More than anyone else, he is responsible for generating billion-dollar sales of testing and supplements. About a quarter of all adults over 60 now take vitamin D supplements. I was disappointed, though not shocked, to read a news report this month from Kaiser Health News reporting that Dr. Holick has been paid $1000/month by Quest Laboratories, who do a lot of vitamin D blood tests, for some forty years. He also received some $163,000 between 2013 and 2017 from pharmaceutical companies who market vitamin D supplements and other bone-related medications. He has also received consulting fees from the tanning industry.
Despite hype as to the value of vitamin D for heart health and cancer prevention, a study just reported in November 2018 at the American Heart Association Scientific Session found that daily use of 2000 IU of vitamin D had no benefit in lowering either invasive cancer or cardiovascular events.
What then should you do? If you are outdoors for half an hour most days, whether walking, gardening or just sitting in your chair and enjoying the view, you are getting all the D you need. Those of us in northern climes might want to think of a supplement for those months when getting outside only happens when you are covered head to toe. If you love fish and have salmon or other fatty fish several times a week, or if you are an avid (quart a day) milk drinker, again you do not need supplements. Those over 70, who are not out a lot and do not drink milk (and no, milk in your coffee or on your cereal is NOT enough) probably should consider a low dose supplement. 1000 IU daily is plenty. Too much D can have harmful effects, and vitamin D is not easily eliminated from the body the way the B vitamins and C are.

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Monday, January 21, 2019

Is that really a good alternative?

As regular readers of these posts or Prescription for Bankruptcy know, I am very concerned about the influence of the pharmaceutical industry on doctors’ choice of therapies. They push hard, through multiple channels, for us to use new expensive treatments that offer only modest if any improvement over older ones. Big Pharma, however look like choir boys when compared to the proponents of many “alternative” treatments. Before the FDA allows a drug on the market, the manufacturer must do studies to show that it works and is reasonably safe. There is nothing similar for a new surgical procedure, but proponents of a new technique will generally perform studies comparing it to “standard” surgeries. So-called “alternative” treatments rarely if ever do such testing and rely on enthusiasm instead.
Non-traditional treatments have a long history. Through much of human history, well into the 20th century, traditional medicine did not have much to offer most illnesses, so it was natural for sufferers to turn to anyone who offered hope. The “treatment” with the longest history was faith-based: prayers and offerings to God or the gods were at times followed by cures. 18th and 19th century America had travelling wagons purveying various nostrums for any ailment. Newspapers of the 19th century were filled with ads for such products as Lydia Pinkham’s herbal tonic (whose most active ingredient was alcohol).
One would have thought that as modern medicine became able to offer therapies that actually did improve or even cure illnesses, the “alternative” practitioners would have faded away, but they are still very much with us. Nowadays, purveyors of megavitamins, colonic cleansing and chelation therapy have the wonderful medium of the internet to spread their message. While it puzzled me for some time why these messages took root, I am beginning to understand. The most obvious reason is that even as we enter the promising new era of gene-based therapy, there remain diseases doctors cannot cure. If a physician tells you this, why not seek answers elsewhere? Most therapies that traditional physicians suggest have data behind them: studies showing that they work better than alternatives (or placebos). The same cannot be said for most “alternative” therapies. What you will see instead are testimonials and/or unsubstantiated claims, often by an attractive person in a white coat. Since placebos work – a certain number of sufferers will be made better by an attractively colored sugar pill – it is easy to find success stories for any therapy.
Alternative medicine is big business. A study I saw in the Toronto Globe and Mail estimated world-wide sales approaching nearly US$200 billion. Social media are widely used and misused by the unscrupulous. Russian trolls not only tried to influence elections in France, the U.S. and Eastern Europe, but they are prominently pushing “anti-vaccination” theories to receptive audiences. While people should be free to spend their money on unproven treatments if they wish to do so, it should be incumbent on agencies such as the FDA and FCC to forbid totally unsubstantiated claims and fine offenders. Studies have found that 40% of Americans believe that alternative therapies can cure cancer. The truth is that a 2018 study from Yale found just the opposite: that patients who used “alternative” therapies had 2.5 times the death rate of those who used conventional treatment.
If you still feel that “alternative” therapies are worth trying, work with your doctors and tell them what you are doing. Combining conventional treatment with prayer may well work better than the treatment alone. The same cannot be said for many other treatments, which may even be harmful, but at least do not keep it a secret, as some “natural” remedies may interfere with other medicines you are given.
The best advise to follow is a very old maxim: caveat emptor – let the buyer beware.

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Friday, January 18, 2019

Role up your sleeves!

My favorite moment of the Golden Globes telecast was when hosts Andy Samberg and Sandra Oh brought out an army of workers “from the Echo Park Rite Aid,” armed with needles, to vaccinate audience members with the flu shot. “Roll up your sleeves, Hollywood, you’re all getting… flu shots!” Oh and Samberg exclaimed, as LMFAO’s rap anthem “Shots” started blaring in the room. “You know you wore a sleeveless gown for a reason,” Oh added. Celebrities like Willem Dafoe were seen on camera getting shots while sitting inside the Beverly Hilton ballroom. But just in case any of those stars believed that they are now immune, Variety magazine later burst their bubble by announcing that it was all a fake. A fake it may have been, but hopefully it did raise the profile of the importance of really getting your annual shot. It is not too late. This year’s epidemic has started late.
A recent survey of primary care physicians verified what I already knew too well: misconceptions about flu shots abound. 51% of the physicians answering the InCrowd survey reported that they had to spend time clearing up misconceptions about the shots. First and foremost, you cannot catch the flu from the shot. While some other vaccines are “live attenuated,” that is, they give you a mild illness similar to the serious illness they are designed to prevent, the flu vaccine does not contain any live virus and cannot give you the flu. Another excuse I heard often was “I got the flu shot last winter and then I got sick.” That is because the shot is designed to prevent only influenza, not the myriad other viruses that circulate in the winter. The shot did not give you the cold you would have caught anyway. Another excuse is “I am healthy and will recover.” This is legitimate if you are only thinking of yourself. If you are a healthy 20-40-year old and catch influenza, you will be miserable for ten days but almost certainly will not die. However, think of your parents or grandparents – they may catch it from you and they are more likely to die. The CDC estimated that about 80,000 Americans died last winter from influenza and its complications. A final argument is that some years have shown low efficacy of the vaccine in matching the strain of virus that hits the community. This has happened, but some immunity is better than none. (And this year's vaccine has turned out to be a pretty good match!)
One of the great success stories of modern medicine has been the reduction or near-elimination of formerly dread diseases. Smallpox once decimated Europe and later nearly wiped out the indigenous peoples of America when the Europeans brought it over. Polio was the scourge of western countries as recently as the 1950’s. Measles was rampant in children, and while often a minor illness, did cause serious problems including deaths. Vaccine skeptics abound, and many Europeans as well as Americans have refused to vaccinate their children. The result was the worst measles epidemic in a decade in Europe last year, with 60,000 reported cases and at least 40 deaths among children. These and many more are preventable diseases – but only if you and your family get your shots!

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Monday, January 14, 2019

Medicine meets Madison Avenue

Today’s post was prompted by a UPS delivery. A big brown truck pulled up and the driver handed me a large but light cardboard box. In the box was a rolled-up poster with sticky tabs at each corner and a cover letter from WedMD suggesting that I hang the poster in my exam room “for the benefit of my patients and their families.” The top 2/3 of the poster had marginally useful information about the common cold and the lower third had pictures of name brand OTC cold remedies and the CVS logo. Useful? Maybe. Promotional? Clearly.
This delivery did provide a great segue into discussion of a paper published in the January 1, 2019 edition of the Journal of the American Medical Association titled “Medical Marketing in the United States 1997-2016.” Advertising has been with us for a long time, and it clearly works. Google’s billions are earned by its ability to target adds to potential customers. In the medical domain, direct-to-consumer (DTC) ads have been clearly linked to both higher demand for and prescription of advertised products. It is thus no wonder that spending on DTC advertising rose from $2.1 billion in 1997 with 79,000 ads to $9.6 billion in 2016 with 4.6 million ads, including 663,000 television commercials. As I note in Prescription for Bankruptcy, the TV ads have a common format. A sad subject, often videoed in muted colors or black and white, bemoans their inability to care for their family or enjoy life. Enter the magic potion and the sun shines, bright colors appear and their life is restored. This is followed by a rapid reading of the mandated side effects that are clearly outweighed in the viewer’s mind by the benefits. Nowhere in the ads are the magnitude of benefits mentioned, which are often small, nor any alternative treatments.
A more recent addition to the advertising armamentarium has been “disease awareness campaigns.” While these can be helpful in destigmatizing diseases such as mental health problems and HIV, more often they simply drive people to demand treatment for conditions that do not respond to the suggested treatment – think “Low T,” driving men to demand testosterone replacement for normal aging
Even larger sums are spent on marketing of pharmaceuticals to physicians, though this has always been a focus of the drug companies and so the increase in spending is less dramatic. In 1997, $15.6 billion was spent marketing pharmaceuticals to health professionals, and in 2016 this had risen to $20.3 billion. This includes samples (always for new and expensive products), coupons and visits by “detail reps” bringing lunch to doctors’ offices. While doctors will generally insist (and may even believe) that they cannot be influenced by a free lunch, ample data exists to show that the opposite is true. Numbers of targeted prescriptions written track closely to the number of meals provided.
Now joining the ranks of pharmaceutical companies in delivering DTC ads are many hospitals and cancer centers. These ads typically tout “new” high tech procedures such as robotic surgery even when there is no clear scientific evidence that these procedures offer any benefit over established techniques. Cancer centers often provide testimonials from satisfied patients rather than meaningful outcomes data.
Knowing that detail reps are no more providing unbiased data than are car salesmen, doctors should refuse to accept their visits, as many academic centers now insist. Advertising is probably here to stay. It clearly provides return on the dollar, and in the US (one of only two countries in the world to allow DTC pharmaceutical adds; the other is New Zealand), courts have declared such ads to be allowed under freedom of speech. What I hope the FDA and/or FTC will do is insist that such ads be more factual. If a new drug is only marginally better than an old one, this should be spelled out in specifics. If a new procedure is more expensive but has not been shown better than other forms of treatment, this needs to be clearly stated. Putting your health on the line has much greater consequences than which laundry detergent you buy, and Madison Avenue must be forced to accept this.

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Thursday, January 10, 2019

What IS health insurance anyway?

As we get caught up in the debates about “Obamacare,” Medicare for all, single-payer and other fighting words, it would do us well to step back and ponder the fundamental question of what health care insurance should do. The basic idea behind any form of insurance is that some us will suffer a calamity: our home will burn to the ground, we will drop dead at 32 leaving a spouse and two young children, we will be hit by a distracted driver or we will develop cancer. Actuaries can predict how many of us will suffer these events but neither they nor we can say exactly to whom it will happen. By pooling our resources, we can each contribute towards the expenses of those who do suffer the calamity.
Through most of human history, medical care was neither terribly effective nor expensive. Doctors comforted and advised, but their fees could be paid by most, and if not, a chicken would do. As we moved into the 20th century, medical care became much more life-saving for serious conditions and dramatically more expensive. The original Blue Cross plans sprang up to cover the cost of going into the hospital for operations. Over time, this idea of having insurance to cover large unexpected bills has morphed into health insurance paying for checkups, routine consultations, all prescription drugs and every test. If you want an analogy, think of auto insurance as covering new tires, oil changes and all your routine maintenance. Imagine what that would do to your premiums! Using health insurance to cover every small-ticket item as well as the big ones adds enormously to the overhead cost that now consumes 25% of our health care dollars.
Premiums for most forms of insurance are set to cover the expected costs that will be paid out in claims plus the insurance companies’ operating costs and a profit. Hence the physical you get before buying life insurance and thus the “safe driver discounts” and surcharges for at-fault accidents on your auto insurance. Hence also the health insurers’ traditional refusal to cover pre-existing conditions and their attempts to “cherry-pick” healthier enrollees that I discuss in Prescription for Bankruptcy. While many have used this to paint the insurers as “the bad guys,” the insurers were simply behaving the way they should in a capitalist economy. They prefer to insure cheap healthy customers to sick expensive ones. Doing otherwise would fail their fiduciary duty to their shareholders.
The only way around this conundrum is to have the entire country in one big “risk pool.” The young and healthy would not get good value for their premiums or tax dollars, but that is no different than the fact that I paid my life insurance premiums year after year and hoped I was wasting my money! I am not a Supreme Court Justice (nor even a lawyer), so I will not comment on the constitutionality of requiring all of us to have health insurance. I will point out, however, that at least 48 of the 50 states require drivers to have liability insurance as a condition of having a car (and the two that do not require a cash bond if drivers do not have insurance). I will also note that a study just published in Health Affairs found that 19% of Californians would not have purchased health insurance without the mandate, most of whom were young and healthy, and that this would have increased premiums for those who did.
As we hopefully move toward universal health insurance, eliminating the fear of bankruptcy from illness, it would also be wise to consider NOT making this a no-deductible, 100% coverage plan. Covering every American against burdensome costs of medical care does not have to mean “no expenses.” This would be a more generous plan than any in the comparable western countries to which we are unfavorably compared and would escalate costs. Since a $50 co-pay looks very different to a business executive than it does to a clerk at Walmart, out-of-pocket expenses can and should be income-adjusted, but having some skin in the game would help all of us realize that medical care is not “free.”

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Monday, January 7, 2019

The poor ye shall always have among you (but not for as long as the rich)

In every corner of the world, the rich live longer than the poor. This is equally true in the United States. In mid-December, the Associated Press analyzed life expectancy collected by the National Center for Health Statistics by census tract. The 65,662 census tracts are geographic areas in which about 4000 people live. The AP found that high unemployment rates, low rates of graduation from high school, low household income and higher percentages of black or Native American residents all were associated with lower life expectancy. While life expectancy varied by state – Hawaii had the highest life expectancy at 82 years and Mississippi the lowest at 74.9, with the national average being 78.6 -the in-state variation by census tract was much more dramatic. In New York, children born in the northern half of Roosevelt Island between 2010 and 2015 had an estimated life expectancy of 59, while those born in Chinatown in lower Manhattan (6 miles away) were expected to live 93.6 years! Massachusetts is a generally wealthy and well-educated state, and the average life expectancy is 80.7 years, but within the state, huge variations also exist. In the census tract with the lowest life expectancy, 45% did not finish high school and 13% were unemployed; the people were evenly split between Hispanics and non-Hispanic whites. In the neighborhood with the highest life expectancy, only 1% did not finish high school, 2.7% were unemployed and the population were mostly white.
Why is this? For people to be healthy, it is clearly helpful to have adequate access to medical care. They need to have doctors and hospitals available, get immunizations, get appropriate screening tests and be able to afford their prescribed medications. They also need to have access to good food and housing and to have good health habits, including exercise, smoking avoidance and avoidance of excess alcohol and drugs.
The disparities are many and varied. A study published in JAMA Network Open in November 2018 found that people who suffered cardiac arrests in the poorest neighborhoods around the country had longer delays in getting emergency care than did similar patients in richer neighborhoods. Maternal morbidity, which I discussed in a prior blog, more often affects poorer black women. A study published in the journal Obstetrics and Gynecology found that severe morbidity occurred almost twice as often in black mothers than in non-Hispanic white mothers.
Living in a neighborhood with lots of trees and other greenery was found to improve many markers of cardiovascular health in a study published on-line in the Journal of the American Heart Association last month. Not only greenery but “greens” are important. People living in “food deserts,” as I describe in Prescription for Bankruptcy, have a higher burden of cardiovascular risk factors, and are much more likely to be readmitted to hospital after being treated for congestive heart failure.
Social media were abuzz in November when a 60-year old woman was denied being listed for a needed heart transplant because of her finances and was advised to start a fund-raising effort. After she raised more than $30,000 via GoFundMe, she was added to the transplant waiting list. Hospital officials defended their behavior, which is very common at all transplant centers, by noting that patients must be able to afford expensive medications after transplant to prevent rejection or the organ, which is in very limited supply, may be wasted.
Among the many diseases that disproportionally affect the poor, cancer may be the cruelest. The poor are less likely to get early screening and more likely to delay seeking care because of cost concerns. Cancer treatment often makes the patients unable to work, a huge problem for those with limited resources on which to fall back.
Gallup’s annual Health and Healthcare poll last year found that 29% of Americans held off seeking medical care because of financial concerns, and 19% said the delay involved a serious condition. Not surprisingly, this behavior varied by income. Those who said they delayed medical care due to cost were 22% when family income was $75,000 or more, 34% when it was $30,000-$74,999 and 38% when it was less than $30,000.
If we can bring the cost of care down closer to that of other Western democracies, we can surely see that all our fellow citizens have access to care. We must also begin to chip away at the social factors that play such a key role.

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