April 26, 2015

The Military Hides Medical Errors from the People It Harms

We’ve learned a lot in recent years about how the impact of medical mistakes and malpractice can be somewhat less devastating when the parties who commit them cop to the bad outcome. But like so many other medical providers,the U.S. military, apparently, has decided such acknowledgment is not its mission.

In a story called “Service Members Are Left in the Dark on Health Errors,” the New York Times illuminated how 1.3 million active-duty service members are particularly vulnerable to the ravages of medical error because they are “ virtually powerless to hold accountable the health care system that treats them.”

When members of the service are ill or injured, unless they get specific approval, they must get care through the military system, even if they believe that care is substandard or dangerous. They’re doubly jeopardized because if that military care causes harm or death, they and their survivors have no legal right to challenge it or file malpractice suits.

“Only 18 months ago, “The Times reported, “did the Pentagon explicitly allow them to file complaints about their treatment, although some had done so earlier. But even then they are barred from learning the results of any inquiry. Under federal law, investigations at military hospitals and clinics are confidential, in part to keep the findings from the roughly 2 million civilian patients they treat per year — spouses and children of service members, retirees and others — who can and do file malpractice claims.”

Nowhere is this loss of rights more poignant than in the story of soldier T.J. Moore, a 19-year-old undergoing basic training. After a gentle 1.5-mile run, Moore collapsed and was rushed to a hospital. He died, and his squadron leader, Lt. Col. Chad Gallagher cried when he told his mother, Anita Holmes, ‘I didn’t do enough to protect T. J.’ ”

She’s still wondering what he meant.

Experts who reviewed Moore’s medical records found a serious medical error at the Air Force base clinic: Moore had been allowed to make the run even though doctors had stopped him from training a few days earlier when he failed the same test. It turns out he had a genetic condition that can result in sudden death during physical exertion.

Not that the Air Force said anything — its report to Holmes, after months of inquiries, was that the military had followed proper protocol, that no mistakes were made and nobody was at fault.

“I raised T. J. as a single mother on little income for 19 years, and kept him safe,” Holmes told The Times. “They had him for nine days and sent him home to me in a box.” She said the report was “garbage.”

Her story is not unusual.

The Times interviewed active-duty patients, relatives and military workers who disclosed that it was next to impossible to get anything but limp letters of condolence or denials of substandard care from the military, never mind anything close to useful information. Sometimes, harmed patients and families got nothing but silence.

“There is just no transparency,” a retired military intelligence officer told The Times. “You can’t sue. You have no insight into the process. As active duty, we just don’t have much recourse.”

The newspaper learned that until 2009, practitioners known to have provided poor care to active-duty patients usually were not reported to a national database that tracks problem medical workers, only to an internal database. Today, such clinicians, typically doctors, usually are reported only if the service member is disabled or dies. That’s a higher standard than in cases involving civilians.

Where’s the accountability in this system of 54 hospitals and hundreds of clinics that, as the paper has reported, often fails to conduct safety investigations that the Defense Department mandates when patients suffer serious harm or die?

Dr. Jonathan Woodson, the Pentagon’s top health official, told The Times that despite the federal confidentiality, the military requires its medical staff and facilities to be open and accountable to all patients.

Then why does the military culture continue to make it so hard for service members to complain? And why, when they do, are their concerns ignored?

A big part of the problem is the 1950s-era immunity established by a Supreme Court decision called Feres, which the Court based on the idea that allowing military members to sue for malpractice or other negligently caused injuries could be bad for military morale. Congress could reverse the doctrine easily but has never done so, partly out of the misguided hostility to legal accountability that some members of Congress bear toward all types of lawsuits by injured people.

So until Congress acts, there is no legal accountability for any service member injured at a military hospital, no matter how egregious the fault or how bad the harm.

Before she retired, the intelligence officer had seen an Air Force physician assistant three times for breast pain and other symptoms she feared might be cancer. Not only were her fears dismissed as irrational, she said, she was threatened with a note in her file that could have damaged her career if she continued to seek treatment.

Nine months later, she was allowed to switch her care to a Navy hospital doctor who discovered Stage 2 invasive breast cancer. Her persistence, she was told, had saved her life, after a double mastectomy and chemotherapy.

After she recovered, she filed a complaint against the physician assistant in an effort to protect other patients. The chief of medical services denied that she had been mistreated. The physician assistant was promoted.

Even a lieutenant colonel whose job involved assessing military hospitals fell victim to the military’s shocking lack of compassion, responsibility and legal redress. He nearly died from a surgical infection that required three additional operations and months of follow-up care. He asked whether the mandatory safety investigation had been conducted, but no one from the hospital staff responded.

He retired for medical reasons in 2013. “I had no faith whatsoever in what I was doing anymore,” he told The Times.

The federal confidentiality law is supposed to encourage medical workers to speak up about mistakes without fear of provoking malpractice suits that are the right of civilians harmed by medical error. The evidence speaks to the misguided nature of that approach.

We’ve written about the cleansing effect of admission and apology, and The Times recalled how, in 2001, the University of Michigan Health System decided that officials would inform patients and apologize on discovering a serious preventable error or lapse in care.

“Administrators say physicians and nurses have grown more open about mistakes — not less — even though, unlike their counterparts in military hospitals, they can be individually sued for malpractice,” the paper said. “The hospital has followed its disclosures by negotiating compensation, resulting in lower malpractice costs.”

It’s time not only for the military to step up to its medical responsibility, but to facilitate the legal rights of the people whose very jobs protect them for everyone else.

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April 24, 2015

Q&A on Medicine’s New Horizons with Dr. Robert Wachter

Dr. Robert Wachter is a familiar name among patient safety advocates. He is credited with coining the term “hospitalist” for doctors who focus on the care of hospitalized patients, and his latest book, “The Digital Doctor: Hope, Hype and Harm at the Dawn of Medicine’s Computer Age” concerns the risks and rewards of health care increasingly dependent on this technology.

Following are excerpts from an interview Wachter did recently with KaiserHealthNews.org. on trends in health-care safety.

Q. Many older people aren’t tech savvy. They’re also bigger health-care users than many younger people. What needs to be done to help them get and stay engaged as technology advances?

A. It’s not natural for them the way it is for the next generation and beyond. But most older people are at least using email and know how to surf the Web. … As consumer-oriented tech companies enter the health-care field, I think they’re going to design tools and technology and ways of interfacing that make it seamless for the people who need to become engaged. This will allow older patients to at least do the basic stuff, like renewing their medications, the stuff that’s just incredibly annoying in the paper world.

Q. In your book, you talk about moving away from fee-for-service payments to doctors and hospitals and toward payments based on a population of people, adjusted for their baseline health. From a patient perspective, will that change how they pay for their care? Could that finally mean the end of incomprehensible “explanation of benefits” insurance forms, for example?

A. Of all the nuts we have to crack, this is the one I’m least optimistic about.

If everybody is in an accountable care organization [doctors, hospitals, laboratories, etc., that coordinate care for higher quality and who are paid according to the quality standards they reach] … providers get a single payment when they treat someone. But as long as they’re still doing an adjustment for the relative sickness of the patients, the organization will need to account for all of the details. And I’m afraid the patient may also still see a confusing itemized bill, unless we can get to a point in which you’ve paid for the year and you’re done.

The movement away from piecemeal payments is hopeful, and so are the digitization of health care and the entry of Silicon Valley companies with a consumer sensibility. I guess the question is: Do all of those trends — when woven together — lead to something that’s more user friendly? When it comes to clinical care, I think the answer is yes. I see how we can get to a much happier place, with better care through digital medicine, in five to seven years. But the idea that you could get a simple, clear insurance bill that you pay with one click … maybe in 10 to 15 years.

Q. To what extent can technology really help people comparison shop for health care? This seems to work best for procedures like colonoscopies or MRIs, where the service performed is fairly comparable and relatively inexpensive. Could people really comparison shop for cancer treatment? Would we want them to?

A. Sure, why not? Some of this comes down to your fundamental belief in capitalism and the market. But we do have to pay some attention to fundamental differences between health-care and other markets. For example, in health care, we can’t accept haves and have nots, while we readily accept this with other luxury goods. … I’m pretty convinced that if you create an environment where patients have the information they need to make those decisions, that the market will help them make good choices.

The area I worry about is the science. How do we really know that one doctor or hospital is better than another? Most aspects of quality measurement are not very advanced.

Another real challenge is fragmentation. If I get my colonoscopy at one place because it’s the best and cheapest but it’s in a different system than the one my primary care doctor is in, that’s a problem if the electronic records don’t talk to each other. As a patient, I’ve got to think about the advantage of receiving the cheapest procedure compared to the negative consequences of no one doctor having a complete view of my health.

Q. Do you think the Affordable Care Act requirement that people have health insurance positively affects their engagement in their own health care or the health-care system?

A. I think everybody should have health insurance. The system works better and people have better health and health care with universal insurance. And the law was the most politically feasible way to make that happen, … When people have health insurance, it creates a connection to a system that is largely mediated through a primary care doctor. To have 40 to 50 million people floating outside the system – able to access the system only episodically and when they’re very ill – is crazy.

Has having insurance increased their engagement? Yes, but at a level that’s pretty wimpy. Now you can see a primary care doctor to manage your blood pressure in an office visit every six months, but is that the level of engagement we should aspire to? Nowhere near it. The hope is that by having everybody part of an organized health-care system, now it’s in the interest of the system to have engaged patients – since that engagement should lead to fewer office visits, ER visits, and hospitalizations. But this is the sort of thing that takes years, if not decades, to develop.

Q. What about initiatives like OpenNotes that allow patients to read their doctors’ electronic notes about their care? How do they change the patient-doctor relationship?

A. OpenNotes illustrates the democratization of the health-care system, which is going to challenge all of the system’s fundamental underpinnings. Digitization is an enabler. It’s changing the relationship between doctors and their patients from an extraordinarily paternalistic one to one that is more democratic. In the new world, a patient’s choice is no longer just, “Do I see doctor A or B?” but “Do I even need to see a doctor at all?” OpenNotes is part of this trend.

As wonderful as patient sharing access to their information is, along with new tools to self-manage and things like telemedicine that allow patients to receive care outside the traditional system, in a world of high copays you are going to see some patients making some very bad choices. In the old days, the sick patient had to go see a doctor. Now they can go to MinuteClinic. Or they can Google their symptoms. I wouldn’t want to turn back the clock, but it raises the question, “When is self-management a bad choice?”

As health care finally goes digital, some people believe that it’s no different than travel or banking. But no one is getting harmed by using TripAdvisor or Fidelity. I think you could argue that health care is fundamentally different.

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April 23, 2015

Confusing Correlation with Causation

We’re all familiar with the breathless tone media often take with news about health and medicine. Bad enough that click-bait headlines fail to describe the science, if any, behind the latest breakthrough, but it’s even worse when the stories that follow can’t get it right.

A recent example was described on HealthNewsReview.org (HNR), a tenacious watchdog of accurate health and medicine media coverage. The story concerned a study that ran on the BBC website under the headline “Being overweight ‘reduces dementia risk,’" and on the Washington Post site as “Being fat in middle age reduces risk of developing dementia, researchers say.”

Uh, no, they don’t. And, no, heft does not ward off dementia. At least not according to this research, which was published in The Lancet Diabetes & Endocrinology.

As HNR explained, such a conclusion is a common mistake when journalists confuse “association” with “causation.”

The research was an observational study, not a clinical trial. The latter sets the “gold standard” of science by assessing the safety and effectiveness of something. Observational studies can be useful in leading researchers toward more specific studies and trials by determining associations between specific factors and outcomes.

Clinical studies require researchers to intervene, and observational studies require them to observe.

As HNR explained, “It is precisely these kinds of stories about observational studies – one day suggesting that overweight raises risk … another day suggesting that overweight lowers risk – that contribute to the decline in public confidence in journalism and in science.”

Observational studies can be interesting, and useful, but they are scientifically insufficient to support the sweeping claims made by the BBC and The Post. For a more accurate interpretation of The Lancet study, HNR suggested, see the story by HealthDay: “Could Obesity Help Protect Against Dementia? Large study suggests that possibility, but experts call for further research into surprising finding.”

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April 22, 2015

Feds Try Another Way to Fast-Track Approval for Needed Medical Devices

As we wrote a couple of months ago, the FDA has proposed that some gravely ill people get experimental drugs faster than the normal approval process allows. Now, the feds have issued guidelines for device makers to get their wares approved quickly, if they fill the unmet needs of people with life-threatening conditions.

The idea isn’t exactly new. Since the 1980s, the FDA has had a fast-track program for medical devices that it deems “substantially equivalent” to existing devices. The reasoning behind what’s known as the 510(k) process is to dispense with all or most of the clinical testing required by completely new products in order to get worthy new devices to market more quickly.

The guidelines provided earlier this month for the FDA’s Expedited Access Pathway Program (EAP) promise to fast-track medical devices to market without bypassing the pre-market approval (PMA) application process.

As explained by AboutLawsuits.com, the EAP is an effort to address a critical medical need without subjecting manufacturers to the “highly criticized” 510(k) process.

On the agency’s blog, FDA Voice, Dr. Jeffry Shuren, director of the FDA’s Center for Devices and Radiological Health, explained how the EAP, a voluntary program, is supposed to work. The FDA would work with a device’s developers during the approval process, and would require a Data Development Plan that shifts some data now collected during pre-market approval to post-market use. That means the manufactures wouldn’t have to provide some of their data about safety and effectiveness until the devices are already on the market.

If that sounds like a really bad idea, the feds justify the potential risk by saying they would limit the program to products “likely to predict clinical benefit,” according to Shuren. “Under the EAP, FDA may accept a greater degree of uncertainty if it is sufficiently balanced by other factors, including the probable benefits to having earlier access to the device.”

The program went into effect last week, and eligibility is limited to medical devices intended to treat or diagnose a life-threatening or irreversible and debilitating disease or condition. A device sponsor must submit an acceptable draft Data Development Plan and the device must meet at least one of these criteria:

  • There is no other appropriate alternative treatment or means of diagnosis.

  • It uses breakthrough technology that gives it a clinically meaningful advantage that existing technology lacks.

  • It offers significant, clinically meaningful advantages not achievable by existing technology.

  • Its availability is in the best interest of patients.

Skeptics question the value of the EAP because the FDA routine is criticized for its lousy track record of collecting high-quality, useful post-marketing data. AboutLawsuits referred to a study by the Pew Charitable Trust last year that showed how most FDA-approved medical devices classified as high-to-moderate risk lack publicly available scientific data proving their safety or effectiveness.

The feds have been accused of approving products before requiring their manufacturers to conduct post-marketing studies (post-approval studies, or PAS), so companies often begin selling devices after getting approval and blowing off the follow-up studies.

Most of the time, the Pew research suggested, the FDA doesn’t bother to ask for the post-approval studies and exercises little oversight of them. AboutLawsuits said, “The report found that from 2005 through 2011, the FDA ordered 223 studies for 158 medical devices. Only 48% of those devices deemed high risk were subject to such a study.”

Tellingly, when there is adequate PAS data, the FDA requires the company to change the product label more than half the time.

The “substantially equivalent” requirements of the 510(k) process have been expanded to include products that advertise using new technologies and techniques, and they can be radically different from their predecessors, say FDA critics. They say the term “substantially equivalent” has become meaningless. If the feds couldn’t keep the old fast-track process safe for patients, why are we supposed to believe this one is any better?

Lots of previously fast-tracked products have been recalled because they were found to be dangerous only after they were implanted in patients.

Many metal-on-metal hip replacements and transvaginal surgical mesh products, AboutLawsuits pointed out, found their way onto the market under the “substantial equivalent” test. There was little pre-market testing to ensure their safety.
Their manufacturers, of course, promoted them as “revolutionary” and vastly improved over older devices.

The 510(k) process originally was intended to speed noncritical devices to market; things like bandages and tongue suppressors, not the more invasive, more complicated devices that are implanted permanently into a human body.

The FDA knows it has a problem with fast-track approval. Last summer On July 28, it issued guidance about the definition of “substantially equivalent” to older devices. Shuren’s blog post said the agency is trying to address these concerns in various ways, and promised that the EAP’s priority review process and other aspects of the program should reduce the development cycle for critically necessary medical devices without a lowering of the FDA’s safety and efficacy standards.

We hope so.

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April 20, 2015

High Unnecessary Costs Associated with Mammograms

Mammograms are a wonderful diagnostic tool for breast cancer. Except when they aren’t.

Every year, the U.S. spends $4 billion on unnecessary costs associated with mammograms, primarily due to the scans rendering “false positives” — that is, a false alarm signaling a problem when there isn’t one, or a problem so minor that it never will amount to a true medical concern.

As reported earlier this month by the Associated Press (AP), a study published in the journal Health Affairs found that $2.8 billion of those costs were the result of false positive mammograms, and $1.2 billion were from overdiagnosis of breast cancer — that is, treating tumors that were unlikely to develop into something serious over the course of the woman’s lifetime.

The costs pertained to women who had mammograms when they were 40 to 59 years old. The study used billing data from a major U.S. insurer and involved more than 700,000 women from all 50 states, from 2011 through 2013.

We’ve written many times about how mammograms to detect breast cancer, along with PSA tests to detect prostate cancer, are a double-edged diagnostic sword. Yes, they can detect true problems, but also minor issues and questionable things that are proved irrelevant only after the patient has undergone additional testing, additional risks (such as pain, infection, worry, etc.) and additional costs.

This study is simply the latest scientific evidence that our ability to detect interesting things in the body exceeds our ability to know if they are worth pursuing for the greater health good.

Breast cancer is the second most common cause of death from cancer among U.S. women; about 41,000 die from it every year. Until a few years ago, annual mammograms were recommended for women starting when they turned 40. Like most cancers, breast cancer is more likely to be treated successfully the earlier it is detected, but the standard annual mammogram has become, among many professionals, less “standard” because of its potential to cause more trouble than it might solve.

The new study pegs the cost of breast cancer overtreatment as much higher than previously estimated.

Still, plenty of practitioners support routine screening, and one called the study one-sided.

Richard Wender, head of prevention, detection and patient-support efforts at the American Cancer Society, questioned the study’s assumptions, calling them a "very selective choice of estimates" for the rates of false positives and overdiagnosis.

"There is no debate about the benefits of mammography," he said.

The American Cancer Society continues to recommend annual mammograms for women starting at age 40, but the U.S. Preventive Services Task Force, which advises the government and informs public policy, recommends that regular screening begin age 50.

Even if the cancer society dismisses the study’s finding that women from 40 to 49 were more likely to have a false-positive mammogram compared with women in their 50s, why doesn’t it find the task force conclusions compelling?

Call us cynical, but could it be because it’s in the interests of the cancer society to encourage the use of medical services?

In fact, the new study is not that new; other studies have supported similar findings, and there simply is no medical benefit to a screening test that results in false positive.

As the AP pointed out, the U.S. spends much more on health care than any other country, but still lags other developed nations in life expectancy and other health indicators. So it’s worthwhile to compare the effectiveness of competing treatments, tests and medications.

Spending more on cancer treatment might make sense; another study in Health Affairs found that cancer death rates were lower in countries that spent more on cancer care, and that countries that increased spending the most made more progress in reducing death rates.

But spending more to look for cancer? That’s a different story.

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April 19, 2015

Conflict of Interest Leads to Potentially Risky Ingredients in Dietary Supplements

Last week the New York Times editorialized about conflicts of interest with the FDA that cast an ominous light on the discovery earlier this month of an amphetaminelike substance in diet pills and sports supplements.

The compound, called BMPEA, according to a story in the Los Angeles Times, has not been tested in humans, and is found in a variety of products you can buy over the counter. The ingredient is labeled Acacia rigidula, a shrub that grows in Texas. Industry observers know that that listing an ingredient like this often signals that the manufacturer is trying to disguise a chemical additive as a natural plant substance.

But, according to the journal Drug Testing and Analysis, BMPEA can be produced only synthetically, which is not the form listed on the labels, and whose health risks are unknown.

The journal’s authors said the FDA discovered the presence of BMPEA in dietary supplements in 2013 but did not inform consumers or require it to be removed from the products. “The FDA should immediately warn consumers about BMPEA and take aggressive enforcement action to eliminate BMPEA in dietary supplements,” they wrote. “Physicians should remain vigilant for patients presenting with toxicity from sports and weight-loss supplements as they might contain undisclosed stimulants, such as BMPEA.”

The FDA began researching supplements with Acacia rigidula in 2012, and a year later wrote about the presence of a “non-natural” amphetaminelike substance in nine of 21 supplements tested.

The recent journal study analyzed 21 brands of Acacia rigidula supplements; BMPEA was found in more than half, including Jet Fuel Superburn, Jet Fuel T-300, Fastin-XR.

A spokeswoman for the FDA told the L.A. Times, “While our review of the available information on products containing BMPEA does not identify a specific safety concern at this time, the FDA will consider taking regulatory action, as appropriate, to protect consumers.”

One of the study’s authors, Dr. Pieter Cohen from Harvard Medical School, called the FDA’s response to a potentially dangerous substance “completely inexcusable.”

Some manufacturers seem to be more concerned about patient safety than the government. Vitacost, a division of the grocery chain Kroger, makes a supplement with the so-called “fat-burning” compound, and its representative told the Los Angeles Times that it removed all products from its website that contain BMPEA, including Aro Black Series Burn, the one mentioned in the study, until it could conduct further studies.

As the L.A. Times story made clear, the 1994 Dietary Supplement Health and Education Act of 1994 excused supplements from FDA testing prior to marketing. Studies such as the one in Drug Testing and Analysis fuel the ongoing battle among supplement makers, regulators and researchers over their safety and efficacy. (See Patrick’s newsletter, “Eat. Drink and Be Wary: The Truth About Diet Supplements and Sports Drinks.”)

Unlike scrutiny of prescription drugs, whose trials are reviewed by the FDA and whose permission must be granted before the medicine may be sold to consumers, supplements aren’t subject to this oversight. The FDA is allowed to intervene only after a problem with a product is discovered. As the L.A. Times summarized, the “result has been a cat-and-mouse game in which researchers discover problems, regulators act and supplement makers adjust their products and practices, only to start the process all over again.”

In March, supplement retailer GNC Holdings Inc. settled a case about product ingredients that were not listed on their labels with New York’s Attorney General. It agreed to use DNA-based testing to authenticate the ingredients in certain herbal supplements.

After that case, 13 other attorneys general asked Congress to give the FDA more authority over the supplements industry.

The New York Times editorial pulled no punches, calling the FDA “lethargic” about regulating dietary supplements. The BMPEA incident, it said, “is a classic example of what happens when industry representatives infiltrate the agency that is supposed to regulate them.”

The N.Y. Times lays much of the responsibility for such lethargy at the feet of Dr. Daniel Fabricant. He was a senior executive at the Natural Products Association (NPA), a trade group for supplement makers and sellers, who became head of the FDA’s division of dietary supplement programs in 2011. Last spring, he went back to the trade association, as chief executive. His successive acting directors at the FDA have included the current one, Cara Welch, also from the NPA. “Both dragged their feet on BMPEA,” the paper opined.

The FDA justifies it hiring practices by claiming to need experts from a variety of experience in public health, academia, science and industry to produce the best health outcomes.

That’s not unreasonable on its face: Industry perspective is valuable in helping a regulatory agency understand the effect of its actions on commerce.

But, as the editorial concluded, “[C]onsumer advocates are surely right that putting the industry in charge of supplement regulation is like appointing the fox to guard the henhouse. Clearly, the FDA should not allow industry insiders to fill key positions. A permanent solution is for Congress to enact conflict-of-interest laws forcing employees above a certain grade level at any agency to recuse themselves from official actions that affect a former employer or client, including trade associations and their members.”

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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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