April 17, 2015

Play Hard, but Protect Your Eyes

The weather’s getting warmer, and a lot of people just want to go outside and play. But remember, you can’t hit the ball if you can’t see it, and if you fail to wear eye protection during certain activities, you’re courting injury.

According to the University of Miami Health System, of the 100,000 eye injuries resulting from sports each year, about 42,000 are treated in the emergency room; about 13,500 people with such injuries end up legally blind. Balls, bats and rackets are responsible for most of those injuries, but another player’s elbow or finger also can be dangerous.

Eye trauma resulting from athletic activities can be as minor (but painful) as a corneal scratch on the surface of the eye to a more serious, potentially blinding injury, such as breaking the bones around the eye (orbital fracture) and a detached retina (the light-sensitive lining at the back of the eye is pulled out of place).

Even after the eye heals, glaucoma, cataracts and retinal detachments can develop as a result of an injury. But 9 in10 eye injuries are preventable with protective eyewear.

Here’s what the university’s Bascom Palmer Eye Institute recommends for sports-related eye safety:


  • Wear appropriate eye protection, such as polycarbonate lenses, sports goggles or masks that are properly fitted.

  • People who wear contacts or glasses also should wear appropriate protective eyewear — contacts offer no protection, and glasses are insufficient protection because lenses might shatter when hit by a projectile.

  • Protective eyewear should be replaced when damaged, as it can weaken and lose protective properties.


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April 16, 2015

Funding Shortfall Compromises Food Safety

You have to praise passage of the Food Safety Modernization Act (FSMA) in 2010, the first major overhaul of food safety oversight in 70 years. It gave the FDA additional powers to prevent food-borne illnesses. But you also have to question why Congress still hasn’t appropriated enough money to fulfill the act’s mission.

Within the last couple of weeks, eight people have contracted Listeria from contaminated ice cream. Listeria can cause serious and sometimes fatal infections in young children, frail, the elderly and people with weakened immune systems. Others might suffer high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, and pregnant women can miscarry or experience a stillbirth

Just last week, 30,000 cases of hummus suspected of being contaminated with Listeria were recalled. Luckily, at this writing, no one has gotten sick.

But what’s the problem with funding food safety?

Last week the New York Times reported that although the nonpartisan Congressional Budget Office (CBO) determined that $580 million was required to enable the FDA to do its food safety job between 2011 and 2015, the agency has received less than half that amount.

As the feds prepare this year to issue critical rules under the new law that would require even more funds, the situation grows more concerning.

In an interview with the newspaper, Deputy FDA Commissioner Michael R. Taylor said, “I don’t think it’s too much to say that the success [of the overhaul] is on the line. We have good plans for moving forward. The problem is we don’t have the money.”

About 48 million Americans get sick from a food pathogen every year. And about 128,000 people are hospitalized each year with food-related illnesses, and about 3,000 die.

Some lawmakers say the White House and the Department of Health and Human Services (HHS), of which the FDA is a part, share some of the blame for insufficient funds because they tried to impose user fees on the food industry to subsidize the law. But the FDA, The Times noted, relies on user fees for lots of programs. Why not this one?

Because industry lobbyists objected, and Congress caved.

The FDA proposed user fees in five consecutive budget requests. Last year, it sought $263 million for the law, $229 million of which would come from fees on food companies.

The FDA got $27.5 million for the law for this fiscal year, and asked Congress for $109.5 million for the next year. The Republican-led Congress likes to cut spending, so it doesn’t look good for the FDA. Even if the agency gets that money, it’s only about half of what the budget office says is necessary, and the cost of addressing food-borne illnesses will continue to be in at least in the millions, and probably the billions.

The FSMA makes food companies responsible for ensuring sure that their products are safe; it doesn’t rely on FDA inspectors, whose numbers are insufficient for the job. As The Times explained, the act demands better record-keeping, contingency plans for handling outbreaks and strategies for preventing the spread of contaminants. Critically, it allows the agency to issue recalls, which it could not do before.

Consumer groups have criticized the Obama administration for dragging its feet in bringing the FSMA to its full powers, and some sued in 2012 to force the FDA to issue its final rules sooner. Settlement of that lawsuit resulted in the agency publishing some of the final regulations later this year.

Taylor, from the FDA, said that his agency could issue some new rules, including those for produce and processed foods, but that lack of funding would undermine its ability to modernize inspection processes, retrain inspectors and other staffers for the new requirements and provide guidance and technical assistance to the states, which conduct inspections under contract with the feds. And you can forget about properly overseeing food imports.

Under the FSMA, the feds are supposed to boost its inspections of foreign food facilities that export to the United States, but the Government Accountability Office found that the FDA had not kept up with the pace of inspections mandated by Congress.

The FDA was supposed to inspect at least 4,800 foreign food facilities in 2014, according to the accountability office, but managed only 1,323.

Tony Corbo, who represents the consumer group Food & Water Watch, told The Times, “If they don’t have the capacity to enforce it, the law is not going to be worth the paper it’s written on.”

But some consumer advocates are optimistic that food safety will be improved despite the funding troubles. According to Colin O’Neil, director of government affairs for the Center for Food Safety, “It’s going to be a long fight. But I think we will get there.”

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April 14, 2015

Why Should Organ Donors Suffer for Their Selflessness?

In addition to their willingness to undergo a potentially risky invasive procedure for the benefit of someone else, living organ donors also are financially generous. Their out-of-pocket expenses average $5,000 because, although a recipient’s insurance covers the donor’s medical expenses, it doesn’t cover transportation, lodging, child care and lost wages.

So there’s a movement to relieve this enormous burden that could spur an increase in organ donations. Given this country’s extreme shortage of donor organs, that would be w welcome development.

According to Reuters, experts suggest that removing the financial barriers to organ donation might include “careful consideration and testing of potential financial incentives for organ donation.” That is, an ethical way to “get rid of financial ‘disincentives’” to donating one’s organs.

Writing in the American Journal of Transplantation, the Incentives Workshop Group said that any changes in current procedure must pass strict measures of both efficacy and ethics. The group is composed of representatives of the American Society of Transplantation and the American Society of Transplant Surgeons.

“Every person in the chain of an organ donation, except one, profits,” Dr. Daniel Salomon told Reuters. He is an author of the paper and medical director of the kidney and pancreas transplant program at Scripps Health in San Diego.

Tom Mone, CEO of OneLegacy, a large organ procurement organization, told Reuters that “Donor costs should be incorporated into the cost of the transplant. The donor should bear no economic detriment.”

That seems like a no-brainer — when someone is literally giving of himself or herself so that someone else can live, what kind of messed up society expects the donor to pay for it, on any level?

One that isn’t comfortable “selling” body parts.

No credible voice is suggesting that, but that’s the “ick” factor that has kept organ donation a strictly voluntary surrender of organ, time and money.

The workshop group believes that covering a donor’s costs upfront would result in huge, long-term savings for insurers by generating greater organ donation. The United Network for Organ Sharing (UNOS) is the nonprofit organization that manages the nation's organ transplant system under contract with the federal government. It pegged the number of living kidney donors in the U.S. last year at a paltry 5,817.

Salomon said that for every kidney patient that stays on dialysis awaiting a donor organ, the payer (insurance company) loses $60,000 a year.

As of this writing, the U.S. Organ Procurement and Transplantation Network reports that 123,389 people are on the waiting list for a lifesaving organ transplant. Approximately 4,000 die each year.

Reuters pointed out that the 1984 National Organ Transplant Act made donor compensation illegal. But the workshop group says it’s time to consider other incentives that don’t compromise altruism. Families of deceased donors, for example, might have their funeral costs subsidized.

The tricky terrain for living donors was described for Reuters by Elisa Gordon, a medical anthropologist at Northwestern University and a member of the workshop. She said that offering them incentives “is so ethically charged. We don’t know if that would result in exploitation or undue inducement.”

Salomon saw the other side in stark terms: “We have a responsibility to living donors. But, we basically take their kidney and say goodbye.” He supports giving donors lifetime health coverage; some other members of the group members support coverage for a specified time.

Some people worry that any such offer is dangerous. Any loss suffered by a living donor, such as medical costs and wages, some believe, should be addressed, but lifetime care might be seen by some potential donors as an incentive.

“We are the only developed country in the world that doesn’t see health care as a universal right,” Salomon told Reuters. “What a statement it would be about our society if people decided to give an organ so they could get health insurance.”

Working group members seek a balance between burdening people with donation costs and compensating them. Such a balance should be found in certain incentives … but not cash.

Salomon wants a dialogue with the Centers for Medicare and Medicaid Services, private insurers and donors who have experienced difficulty themselves. A fair, ethical solution is unlikely to found without all stakeholders — patients, families and subsidizers — participating in the discussion.

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April 13, 2015

Mark Cuban’s Ignorance Is a Setback for Wise Use of Medical Resources

Mark Cuban is a renowned entrepreneur, owns the NBA Dallas Mavericks and appears on the reality TV show “Shark Tank.” He recently garnered additional attention for his medical opinions. Unfortunately, like so many “celebrities” who are loud and uniformed, his advice is terrible and only serves to undermine best care practices.

As Los Angeles Times columnist Michael Hiltzik put it, “When it comes to health-care policy, he's brash, outspoken and very misinformed.”

Early this month, Cuban tweeted his 2.8-million followers to "have your blood tested for everything available, do it quarterly so you have a baseline of your own personal health."

“Cuban displays an endearingly naive view of how medical data is used,” Hiltzik said, “and as a billionaire a limited sensitivity to the cost of screening.”

Cuban also tweeted, “A big failing of medicine = we wait till we are sick to have our blood tested.”

As we often note, unnecessary testing, the overuse of medical care is not just wasteful, it’s risky. As Hiltzik put it, “For the vast majority of individuals, this is terrible advice, brainless and even dangerous. As a matter of public policy, it's egregiously misconceived.”

Other well-informed medical industry observers also weighed in on Cuban’s bone-headed social media chatter. Charles Ornstein, a highly respected health-care journalist who reports for ProPublica.org, counter-tweeted: "Please don't listen to @mcuban advice to get quarterly bloodwork if you are healthy."

Cuban’s unthinking but powerful actions prompted medical experts everywhere to caution against overtesting. They cited solid scientific studies that demonstrated that excessive testing and screening leads to excessive and unnecessary treatment. We’ve explained that such excess not only causes psychological stress and worry, but presents a risk of infection or other complications from diagnostic invasion.

Because the issue is so important, Ornstein offered to debate Cuban in a ProPublica podcast. Cuban declined. He believes that there more is more, that all data is good. “That may be true for investors who typically want to snarf up all the information they can gather about a company and the market it serves,” Hiltzik wrote, “but in medicine things aren't so simple.”

Just because a screening test is a scientific exercise, that doesn’t mean it always renders a clear indication of what the tester is looking for; it isn’t always definitive that you have a certain health condition or that you don't.

As Aaron Carroll, a health-care economist explained, "When you get a blood test, it doesn’t come back 'sick' or 'well.' It comes back with a number value." The number must be interpreted by comparison with, for example, a population average; by putting it into context of the patient's symptoms. A proper interpretation can take time to observe whether or not there’s a trend, which itself could be important or meaningless.

So more isn’t more; more leads to more.

As Hiltzik recounted, a just-in-case CT scan “doses the patient with radiation and a colonoscopy can leave physical damage. The risk of a false positive -- an indication of a problem that isn't there -- is often greater than the risk of a false negative -- not finding a marker of a condition that does exist.”

That’s why savvy medical professionals have been reluctant to recommend certain screenings that used to be routine annual prescriptions — mammograms, colonoscopies and PSA tests for prostate cancer.

Ornstein referred to the work of Dr. H. Gilbert Welch, an expert on overdiagnosis: "Twenty years ago, a simple [PSA] blood test was introduced. And 20 years later, over 1 million Americans have been treated for a cancer that was never going to bother them. ... It turned out an awful lot of men had abnormal PSAs. Most of these men were treated with either radical surgery or radiation. And roughly a third suffered side effects of treatment generally related to bowel, bladder or sexual function. Even a few have died from it."

Public health policy should not reflect the mindless use of health resources. It should reflect a complete understanding of the state of the science and the art of medicine, it should reflect an understanding of the costs of delivering the best health care to the most people. It shouldn’t reflect the sugar daddy instincts of people too rich and entitled to use their brains instead of their bank accounts.

As Hiltzik concludes, “As a public intellectual, … Cuban isn't especially open to professional advice or hard information. His attitude is that he didn't get where he is today by listening to criticism. But then again, he's a businessman and billionaire entrepreneur, not a doctor.”

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April 12, 2015

Women Get Short Shrift in Heart Attack Care

More than 15,000 women younger than 55 die of heart disease every year in the U.S., and younger women are twice as likely to die after being hospitalized for a heart attack as are men of the same age.

So why do women typically wait much longer than men to seek emergency care for a heart attack, and why, once they’re at the ER, are their symptoms so often misdiagnosed?

That scenario was the subject of a recent report on NPR. It referred to a study published in Circulation: Cardiovascular Quality and Outcomes that interviewed 30 women ages 30 to 55 who had been hospitalized after a heart attack.

Remarkably, many of them didn't know what a heart attack feels like.

The study’s lead author, Dr. Judith Lichtman, an epidemiologist at the Yale School of Public Health, commented to NPR, "We often see it portrayed as someone falling to their knees, holding on to their chest. Maybe we need to do a better job of explaining and describing to the public what a heart attack looks and feels like."

In fact, for women, a heart attack involves not only some chest pain, but usually a host of other other symptoms, including neck pain, jaw pain, indigestion, fatigue and nausea.

Even when women suspect that they might be having a heart attack, many are reluctant to express that they might be having a cardiac problem. They’re concerned, Lichtman found, that they might be wrong, that they might be over-dramatizing things.

Making the situation worse is that doctors often reinforce these fears by assuming that they are suffering from indigestion, or maybe a panic attack, rather than a heart attack.

"So I think it is really critical that we empower women to not feel any stigma or judgment," Lichtman told NPR. She also said that recognizing what’s really happening requires doctors to be better listeners, and when have we heard that before? (See our blog, “When Doctors Don’t Listen, Patients Don’t Thrive.”)

Practitioners also need to pay special attention to women who have high blood pressure or cholesterol, or a family history of heart disease.

The American Heart Association spells out the signs of heart attack in women:


  • uncomfortable pressure, squeezing, fullness or pain in the center of the chest that lasts more than a few minutes, or goes away and comes back;

  • pain or discomfort in one or both arms, the back, neck, jaw or stomach;

  • shortness of breath with or without chest discomfort;

  • breaking out in a cold sweat, nausea or lightheadedness.


As with men, women’s most common heart attack symptom is chest pain or discomfort. But women are somewhat more likely than men to experience some of the other common symptoms, particularly shortness of breath, nausea/vomiting and back or jaw pain.

If you experience any of these signs, summon help within five minutes. If you must, call 911 and get to a hospital right away.

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April 10, 2015

Drink More Water to Avoid Kidney Stones

You might be able to spare yourself the excruciating pain of passing kidney stones with a simple preventive measure: Drink more water.

According to a paper presented at a recent conference of the National Kidney Foundation (NKF), the preliminary results show that people who have a high water intake significantly reduce their risk of developing kidney stones.

The study was a meta-analysis, reported MedPageToday.com, which means it combined the results from many studies, lending more significance to its results.

"This analysis shows that drinking water is an effective way to cut one's risk for developing kidney stones in half," Kerry Willis, PhD, NKF chief scientific officer, said in a news release. "Confirmation of reducing risk through improved hydration is an important finding."

Drinking too much water can lead to a condition called hyponatremia, which can cause confusion and even seizures. But it’s rare, and far more people are at risk of dehydration (and kidney stones) than hyponatremia.

There’s no magic amount people should drink. But a general rule of thumb, according to the American Urological Association and the American College of Physicians, is that people who drink enough to prevent kidney stones produce two to two-and-a-half liters of urine per day.

Of course no one measures their urine output (at least not since Howard Hughes saved the stuff in bottles). But most people can tell if they’re drinking enough by monitoring the color of it — the lighter the color, the more you’re hydrated.

In addition to drinking sufficient water and monitoring the color of your urine, know that what you eat can contribute to forming kidney stones. According to the NKF, you should limit your salt intake, which means avoiding processed foods, fast food and paying attention to labels — sodium hides in additives including:


  • monosodium glutamate, or MSG

  • sodium bicarbonate, the chemical name for baking soda

  • baking powder, which contains sodium bicarbonate and other chemicals

  • disodium phosphate

  • sodium alginate

  • sodium nitrate or nitrite

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April 9, 2015

Obama’s Effort to Address Antibiotic Resistance Is Incomplete

Controlling infections has become increasingly difficult because bacteria are increasingly resistant to the drugs that have been developed to fight them. The White House has been waging a campaign to raise consciousness about antibiotic-resistant bugs for some time, and its latest salvo was launched last week.

Unfortunately, it’s too little and, we hope, not too late.

President Obama described his initiative to improve surveillance of infectious outbreaks, develop better diagnostic tests, boost research into alternative drugs, improve the tracking of antibiotic use and reduce their use.

He also asked Congress to double funding in the war against antibiotic-resistant bacteria.

Since they became widely used last century, antibiotics have become “miracle” drugs that have drastically reduced the number of people who die from infection. But such widespread use — overuse — is precisely why they’re less able to perform miracles now.

Bacteria evolve to develop resistance to their drug predators, so we constantly must develop new ones to combat the old ones’ diminishing power. Some researchers believe that if we can’t get off this treadmill, if we can’t figure out how to halt the trend instead of just staying ahead of it, that the world could return to the time before antibiotics, when people commonly died from ordinary infections.

When Obama initiated the effort last year, the New York Times reported, the medical/health community welcomed the attention it had been seeking for years for the problem of the waning ability to address infectious disease. But many people wish the program had more muscle, particularly against the overuse of antibiotics in agriculture.

The new initiative focuses on moderating the use of antibiotics in humans. It promotes the Centers for Disease Control and Prevention (CDC) as the primary agency to monitor how hospitals and other medical facilities administer antibiotics, and it enumerates steps for hospitals that treat Medicaid and Medicare patients (and therefore receive public funding) to reduce inappropriate use.

“The news here is that the administration is setting specific, annual milestones for tackling the problem,” Allan Coukell told The Times. He’s senior director for health programs at the Pew Charitable Trusts, a research and advocacy outfit that participated in last year’s effort to craft strategy for tackling the problem.

Given our notorious overuse of medical products and services generally, it’s not surprising that Americans use more antibiotics than people in other industrialized nations. According to Pew, we use more than twice as many as Germans and the Dutch.

But you can’t address a problem completely if you don’t have sufficient data, and the White House plan announced last week doesn’t provide it. According to The Times, more than 7 in 10 antibiotics sold in the U.S. goes to livestock, to animals people consume, but producers of meat and poultry are not required to report which antibiotic drugs they use, on which animals and in what quantities.

Scientists note that without that information, it’s difficult to document how routine antibiotic use in animals relates to antibiotic-resistant infections in people.

So although Obama is to be congratulated for finally facing a problem we’ve known about a long time, his approach lacks the total effort required to assess the real power of the enemy. We can, and should, do better.

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April 8, 2015

Making Health Data Trackers Reliable Monitors of Reality

Fitness freaks and gadget lovers have long embraced health apps, and more medical facilities and practitioners also are starting to see the clinical usefulness of reliably tracking individual patients’ data. As a recent story by the Associated Press (AP) made clear, medical providers see great potential in the technology, but also limitations in its current form.

Liability

What if someone’s device registers data indicating an ailment, but no one at the doctor’s office or hospital notices? Wary of that scenario, one hospital, Hackensack University Medical Center in New Jersey, is experimenting with six patients and three doctors to monitor mainly lifestyle data, such as nutrition. It hopes eventually to monitor blood pressure, heart rate and other vital signs, but will defer that decision to a hospital committee.

This tentative approach might be careful and wise, but we wonder if the hospital is more concerned about being sued than helping to make people more responsible participants in their care.

Doctors say patients increasingly bring health data to their visits, often as printouts that someone in the office must scan into a file. So receiving such information electronically through Apple's HealthKit and similar technologies would enable practitioners to see more charts and the patterns within them. Some hospitals envision establishing a team to review this sort of incoming data.

Data Reliability

Many consumer devices such as fitness trackers aren't regulated by the FDA, so how reliable are they as messengers of true and useful information? (See our blog, “FDA Launches First-Ever Probe of Medical App for a Mobile Device.”) The Center for Digital Health Innovation at the University of California, San Francisco, is studying the issue with Samsung. One test involves strapping a consumer device on 100 people and taking measurements as they stand, sit, exercise and sleep. Data would be compared with those from devices known to be reliable.

"Just because it works in a lab on a couple of individuals doesn't necessarily means it works on a broad variety of individuals in real life," Michael Blum, the center's director, told AP.

Privacy Concerns

Data entered into a health-care provider's electronics record system are covered by strict federal privacy laws (such as the Health Insurance Portability and Accountability Act, or HIPAA), which subjects providers to penalties for breaches. But if you've signed waivers as part of insurance claims, your insurer has access to the data as well, and as we’ve written, breaches are seldom punished.

Nicolas Terry, director of the Hall Center for Law and Health at Indiana University, isn't concerned about insurance access to data, noting that the Affordable Care Act (“Obamacare”) includes protections for pre-existing health conditions.

But tech companies that come up with data trackers and apps aren’t subject to these health privacy laws. They might be subject to penalties, according to AP, if they fail to abide by their own privacy policies, but if they never promise to safeguard the information, they are free to share and sell it, Terry told AP.

That’s concerning, whether or not your doctor is using your information for your care. Although a step counter might seem innocuous, for example, it also might record the location of your step.

"Now you have a surveillance system," Terry told AP. "If the people you meet also have wearable devices, we could figure out who you meet."

It’s the same concern a lot of people have when their car insurers offer lower rates if they agree to install mileage trackers — why should an underwriter know not only how much you drive, but where?

Reimbursement

Traditionally, medicine has been dispensed on a pay-for-service model, but thanks to government carrots and sticks, the overuse of services and their increasing cost, Medicare and private insurers are starting to reward doctors for preventive care. Medicare programs that pay doctors a monthly fee to keep patients healthy could involve reviewing fitness data and checking in with patients regularly by phone to identify problems that otherwise might escalate into more costly treatments or visits.

"It is slowly changing ... but it's still challenging to get paid for analysis and for email and phone call time," Dr. John Schumann, an Oklahoma internist who blogs on health issues, told AP.

Other Limitations

Data-dispensing devices and apps give you information, but they can’t ensure that you take the medicine you’re supposed to. Companies are developing sensors to record when you pick up a bottle, but unless you want to keep house with Big Brother, doctors just have to trust that their patients are following through as directed.

Younger people tend to accept technological assistance more readily than older folks, so caregivers would welcome ways to entice their older patients to use data-tracking.

"What we need is data for older people, and they are not doing that right now, with rare, rare exceptions," Dr. David J. Cook told AP. He conducts research at the Mayo Clinic into how trackers and apps can improve care.

Many of the clinic’s hip-replacement patients are older, and because Mayo practitioners want to track their post-surgical progress, it has loaned them Fitbit trackers and Android phones. Instead of keeping a written diary of activity, patients just put it on and turn it on.

If they remember…

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April 7, 2015

Medicare Pay Fix Has an Add-On: Malpractice Protection for Doctors

Last month much attention was paid to the passage of a bill by the House of Representatives to reconfigure how doctors are paid by Medicare. But one of its provisions escaped most people’s attention, and it has a huge potential effect on patient safety. It grants added protection for doctors against medical malpractice lawsuits.

As reported last week by the New York Times, “The bill, which requires the government to measure the quality of care that doctors provide and rate their performance on a scale of zero to 100, protects doctors by stipulating that the quality-of-care standards used in federal health programs — Medicare, Medicaid and the Affordable Care Act — cannot be used in malpractice cases.”

Everyone’s familiar with the comparison of law-making to sausage-making, and that description is apt here, too, as the language in the bill essentially replicates the language doctors and insurance companies wanted to see; that is, special-interest lobbies influenced public policy more than civil justice.

The medical industry claimed that because federal standards and guidelines do not fairly reflect standards of care, they shouldn’t be used as evidence of negligence when something goes wrong in the care of a patient.

But there has to be some kind of standard by which performance is measured, especially when taxpayers are footing the medical bill. Why should doctors and hospitals not receive the same kind of work scrutiny everyone else is subject to?

Insurance companies and federal programs such as Medicare increasingly require providers to report data that are used to review the quality of care. Reimbursement is based on performance as compared with similar providers.

As The Times explained, “Medicare, for example, asks doctors: What percentage of tobacco users receive counseling on how to stop smoking? What percentage of patients develop infections after surgery? What percentage of diabetes patients have blood sugar levels in the normal range?”

And that sort of oversight is only expected to increase as more people are covered by government insurance plans and as medical costs increase.

Providers worry about the increasing reliance on cold numbers, and there are limits to how well numbers represent someone’s skill and the ability to treat patients as individuals, not sets of symptoms.

Brian K. Atchinson is president of the Physician Insurers Association of America, a trade group for insurers. He told The Times that the bill would “eliminate the uncertainty” about how to use federal guidelines and standards in determining legal liability of providers. Rather than an extra layer of protection, he said the bill would, “simply preserve the status quo with respect to medical professional liability.”

But to other industry observers that seems more like a reason to excuse medical providers from paying the attention all patients have the right to expect. “Why wouldn’t you want to take these guidelines into consideration?” asked Tom Baker, an expert on insurance law at the University of Pennsylvania. “They indicate what a reasonable doctor does and should do, just like guidelines adopted by a medical specialty society.”

Other consumer advocates also see the bill’s provision as more ominous than reasonable.

The National Consumer Voice for Quality Long-Term Care told the newspaper that the protection provision would make it more difficult for nursing home residents who are injured to defend their rights, that it would interfere with their ability to prove negligence by showing that a facility had violated federal health and safety standards.

Provider lobbyists want such testimony to come from “experts,” not guidelines. They want doctors to be able to say that other doctors must be able to make decisions they believe are best for a given patient instead of being forced to make a decision based on what the government believes is best for all people with that condition.

That misses the point. No one argues that doctors must have flexibility in treating people; what they’re not allowed to have is a negligent practice. If they make a mistake, the reasons for it should be open to scrutiny by whatever measure can explain it.

The primary goal of the House Medicare bill, which the Senate did not consider before Congress left on Easter break, is to revise the way doctors are paid; it isn’t to address what happens if they’re negligent.

The bill would head off a scheduled 21% cut in what Medicare pays doctors; the Senate is supposed to consider the bill when legislators return April 13.

One of the bill’s sponsors, according to The Times, said the new payment formula would help doctors “get out from under the constant threat of payment cuts” while endorsing a new payment system based on “quality measures.”

“While taking these important steps toward ensuring quality care,” he said, “the bill specifically states that these quality measures are not creating a federal right of action or a legal standard of care.”

President Obama and many representatives, Democrats and Republicans, have endorsed the bill, but how many of them read, or understand, what it means not just for paying doctors, but protecting patients?

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April 6, 2015

Doctors Don’t Bother with Lifestyle Counseling for Mentally Ill Patients

Whether it’s depression or bipolar disorder or schizophrenia, people with mental illness often get medical treatment that perceives them less as whole persons than as a single body part.

According to a survey recently published in the journal Diabetes Educator, more than half of patients who had symptoms of mental illness, and almost 1 in 3 who also had diabetes, said their health-care providers had never discussed reducing their consumption of dietary fat, or engaging in regular exercise.

Although that advice would apply to a lot of people with a wide range of health issues, it’s also important for the mentally ill, because, according to the University of Illinois researchers who conducted the study, they have significantly higher rates of cardiovascular disease, diabetes, hypertension (high blood pressure) and high cholesterol. Those disorders often can be alleviated with lifestyle modifications.

The researchers also said the mentally ill are at increased risk of premature death.

Data for the study came from the Medical Expenditure Panel Survey (U.S. Department of Health and Human Services) that interviewed a nationally representative sample of participants several times over a two-year period about their health and use of medical services.

Symptoms of mental illness were identified by scores on the Kessler Psychological Distress Scale. Known as the K6, it’s a screening tool practitioners use to predict serious mental illness.

Participants in the study ranged in age from 18 to 70. Of those with symptoms of serious psychological problems, more than 15.6 in 100 also had diabetes; only about 8 in 100 without these symptoms had the endocrine disorder.

Rates for all clinical conditions that raise the risk of diabetes generally were higher among subjects who had symptoms of mental illness than among those who didn’t.


  • More than 7 in 10 with mental illness had body mass indexes (BMI) higher than 25 (BMI above 25 is deemed overweight; 30 denotes obesity) versus about 6.5 in 10 of their peers.

  • More than 4 in 10 had significantly higher rates of hypertension versus about 2.6 in 10 peers.

  • More than 4 in 10 had hyperlipidemia (elevated blood fat level) versus about 3 in 10 peers.

  • Almost 3 in 10 had cardiovascular disease versus about 15 in 100 peers.


The study also found that people with symptoms of psychological distress who had not been diagnosed with diabetes before the study had an average of more than three diabetes risk factors, compared with their counterparts, who averaged 2.4 risk factors.

So, clearly, this is a medical population in need of intervention about how to moderate its nonmental disease or how to head it off altogether with behavioral changes. But the likelihood of these people getting such help increased only in accordance with their number of risk factors.

That’s short-sighted, because diabetes is one condition that can be managed much better through lifestyle the earlier you address it.

The American Diabetes Association recommends that health-care providers counsel all patients with diabetes or at high risk of diabetes about physical activity and healthy dietary choices.

Because people with mental illness tend to utilize outpatient, inpatient and emergency services at much higher rates than the general population, said lead researcher Xiaoling Xiang in a university news release, clinicians should use these additional opportunities to educate patients about the benefits of a healthful diet and physical activity.

Diabetes isn’t the only problem that tends to be ignored in patients being treated for mental issues. A couple of years ago we wrote about how psychiatric patients tend to be ignored in emergency departments.

Just because people struggle with mental problems doesn’t mean they aren’t capable of helping themselves, and it’s patronizing to ignore their ability to do so.

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April 3, 2015

Create a Family History

Because many health problems are rooted in your genes, it’s critical to know as much about your family’s cultural and medical history as possible in order for your doctor to make an accurate diagnosis. A handy tool provided by the National Institutes of Health (NIH) enables you to create a family history, and keep it updated.

Family history is a particularly important risk factor in heart disease, stroke, diabetes and many types of cancer. Knowing which of your relatives have or had these (and other) disorders not only helps predict your risk of developing them, but helps practitioners determine which tests and screenings are appropriate for your care. Create a family history in advance of seeing your doctor, and make a copy for both yourself and the doctor’s files.

Family history, of course, is only one part of drawing a health profile; other factors that affect health include environment and personal habits, or lifestyle. Keep in mind that even if a close relative has a certain disease that raises your risk, it doesn’t mean that you will have it, too — it just means your chances are greater, and, more important, that knowing so is an opportunity to reduce the risk through proper screening and by changing your lifestyle, if necessary.

Learn more about the components of a good family health history from the NIH’s inheritance/family history handbook.

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April 1, 2015

Public Objects to Relaxing Rules for Promoting Drugs to Doctors

Last summer, the FDA issued draft guidelines for changing what information drug company representatives must provide health-care professionals about the potential side effects associated with their product. Some of the revisions were 180 degrees different from what drug label warnings are required to contain now, and judging by public feedback, they’re not popular.

According to a recent story on AboutLawsuits.com, public comments to the FDA are almost unanimous in their opposition, and consumer watchdog Public Citizen reflected this wave of disagreement in a letter to Sylvia Burwell, secretary of the Department of Health and Human Services.

The FDA’s draft concerns new risk information, which it defines as “information that becomes available after a drug is marketed that rebuts or mitigates information about a risk already identified in the approved labeling or otherwise refines risk information in the approved labeling in a way that does not indicate greater seriousness or risk.”

For example, the feds could include drug data suggesting that the rate or risk level of a known side effect is lower than what was required for the label when the drug was approved for consumer use.

But how many times have drugs approved for marketing later proved to be much more dangerous than initially believed? To require label revisions or withdrawal from the market after people died or otherwise suffered serious harms? The diabetes drug Actos is an example of the former, when its risk of heart failure was discovered after it was released in 1999. The pain reliever Vioxx was yanked from the market in 2004, also after it was discovered to increase the risk of heart attack and stroke.

Because the FDA had published only one comment to the draft regulations by October, Public Citizen filed a Freedom of Information Act (FOI) request for access to more of what people were saying about the guidelines. By the time the letter was sent, the feds had posted about 80 comments.

According to the organization’s analysis of nearly 1,800 comments reviewed from the FOI request, 99% were opposed to the proposed guidelines for on distributing scientific and medical information on prescription drugs. Most of the comments indicated that the revisions would undermine the FDA’s authority and put patients at risk.

Public Citizen accused the FDA of hiding the clearly negative response — only 11 of 1,782 comments submitted by individuals, organizations or companies supported the draft guidelines. Ten of those were submitted by the pharmaceutical industry and one academic.

Opponents claimed that the revised regulations essentially would give drug sales representatives permission to lie to doctors regarding any serious health risks associated with their products, that providers could ignore them or that they don’t really exist. The relaxed requirements basically would permit Big Pharma to promote drugs “off-label,” which is illegal now.

Off-label use is when a doctor prescribes a drug to treat a condition for which it has not secured FDA approval. It’s not illegal for doctors to do so, but drug companies are prohibited from advertising them for those uses. They’re not allowed to promote drugs for any use until the FDA deems it safe and effective.

We regularly write about companies that routinely ignore this regulation (here and here), sometimes paying huge fines as a result. Of course, they continue to flout the rules because they make more money selling the drugs illegally than they pay in fines or settlements.

Dr. Sidney Wolfe, founder and senior advisor of Public Citizen’s Health Research Group, wrote the letter to Burwell. According a news release quoted by AboutLawsuits, he said, “As most of the comments stated, this proposed guidance is reckless and seriously undermines FDA authority. The FDA is supposed to be the government shield that protects patients when the industry pushes products that might not have a favorable benefit-to-risk ratio in order to line their own pockets. This guidance completely undermines that safety shield.”

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