September 18, 2014

Suggested Reading: Profits, Not Health Status, May Be Driving Patients Into and Out of Hospice Care

A recent installment of The Washington’s Post series on “The Business of Dying” is not for the faint of heart. Like an earlier story we blogged about a few months ago, this one is about how hospice care is being abused by the agencies that profit from it.

According to Medicare, to enroll in hospice care, a patient’s life expectancy must be six months or less. Treatment is about comfort, not cure, and it’s intended to last until death.

But, as The Post reports, more than 1 in 3 U.S. patients leave hospice care before they die. “When that many patients are leaving a hospice alive,” the story says, “the agencies are likely to be either driving them away with inadequate care or enrolling patients who aren’t really dying in order to pad their profits.”

Although about 15 in 100 hospice patients are properly released before death because their health unexpectedly improves, that is not what seems to be happening at some such facilities, especially new, for-profit companies, where the release rate is far higher than those figures.

The Post says this might be because:

  • Some hospices forsake patients when their care becomes expensive.

  • Some hospices enroll patients who aren’t actually dying.

Read the whole story here.

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September 16, 2014

FDA Oversight Lags for Consumer Apps, but Improves for Industrial Lab Tests

As consumer interest in medical treatment becomes increasingly gratified with downloadable apps and as industry develops ever more diagnostic tools, the opportunities for misinformation and misadventure increase as well. This summer, the FDA admitted that it could little about the former, but will regulate the latter.

As reported on PBS News Hour, the quantity of new health applications available on the market every year outpaces the FDA’s ability to regulate them.

Some Congressional representatives have advocated for a special department within the FDA to address the proliferation of mobile health apps, and to regulate them, but the idea has been rejected as impossible to fulfill by the agency’s policy advisors.

The feds have reviewed about 100 health apps, and they have published guidelines for the app industry and its own staff that, according to the story, frees developers of health-care information technology to create products free of regulatory oversight, even if they cross the line between medical devices and information. Those guidelines were a follow-up document to last year’s guide to help app developers know if their product would qualify as one that requires oversight.

The latest document pretty much confirms that the FDA’s intention is not to scrutinize all health apps, especially ones deemed low-risk, such as exercise tracking tools. It intends to focus on apps used as accessories for a regulated medical device or those that “transform a mobile platform into a regulated medical device.”

So app users, make sure you understand the difference. To learn more about how the FDA oversees medical apps, link here.

Diagnostic tests are a different kettle of fish, regulation-wise. As reported, the FDA will assume regulation of so-called "home brew" diagnostic tests developed and used within individual clinical laboratories. The goal, according to its announcement, is “to ensure that certain tests used by health-care professionals to help diagnose and treat patients provide accurate, consistent and reliable results.”

The FDA notified Congress that it will propose a framework for laboratory developed tests (LDTs) designed, manufactured and used within a single laboratory, such as some genetic tests and tests that are used by health-care professionals to guide medical treatment for their patients.

Currently, labs certified under a program managed by the Centers for Medicare and Medicaid Services may develop and use their own diagnostic tests internally without FDA oversight. Many genetic tests and some unique infectious disease diagnostics fall into this category. Reagents — substances or compounds used in chemical analysis or other reactions — are regulated by the FDA, but no clinical data are needed for their approval.

According to MedPageToday, FDA Commissioner Margaret Hamburg said the agency was “very concerned” about the growing use of LDTs for cancer and other serious diseases because their accuracy hasn’t been verified. She professed awareness of faulty LDTs that could expose patients to inaccurate diagnosis, which in turn puts them at risk for getting the wrong treatments.

Until now, the feds pretty much laid off these internal lab tests because LDTs were used only for rare or low-risk diseases. Officials didn’t believe that regulating them would be helpful or necessary. But advances in molecular biology have greatly expanded the ability of clinical labs to develop and market tests for a wide range of disease markers, and that means the potential for risky error is so large it should be monitored.

The agency also justified its expanded authority because all diagnostics should be subject to a common standard. "While the FDA has historically exercised enforcement discretion over LDTs (generally not enforced applicable regulatory requirements), today these tests may compete with FDA-approved tests without clinical studies to support their use," its statement said.

As MedPageToday noted, the FDA already oversees direct-to-consumer tests regardless of whether they are LDTs or traditional diagnostics.

The FDA’s proposal for stronger LDT regulation adds a layer of patient protection especially to the burgeoning field of personalized medicine. That’s treatment customized according to a patient’s unique, individual traits and has application, for example to things like what kind of chemotherapy, how often and in what dose should be given to a cancer patient with a certain genetic profile.

Although the additional oversight is welcome for patient safety, it won’t happen overnight — the FDA plans to roll out the complete program over several years. Industry, as well as the public, will have the opportunity to comment on the proposal. To learn more, link here to the FDA announcement.

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September 15, 2014

Breast-Sparing Surgery Shows Better Results in Some Cancer Patients

A preliminary report shows that surgery that spares the breast in patients with a certain kind of early-stage breast cancer has better survival rates than mastectomy.

The study findings, reported Consumer Affairs, “defy the conventional belief that the two treatment interventions offer equal survival, and show the need to revisit some standards of breast cancer practice in the modern era, …”

Breast-conserving therapy (BCT), according to a paper presented at the Breast Cancer Symposium earlier this month, involved lumpectomy plus radiation for patients with early-stage, hormone receptor-positive breast cancer. Lumpectomy is the removal of only the mass with the tumor, not the whole breast (mastectomy). Hormone receptor-positive breast cancer (HR+) is when the cells have receptors for either estrogen or progesterone, which invites growth. Hormone receptor status is a primary factor in how a patient’s breast cancer is treated.

In the 1980s, according to Consumer Affairs, studies concluded that (BCT) and mastectomy were equal in terms of survival among women with early-stage breast cancer. But because those studies were conducted when not much was understood about breast cancer biology — for example, subtypes, how and where it recurs and its potential to metastasize, or spread beyond the original site — they don’t have much relevance in today’s more advanced cancer analysis.

As reported by, the study’s data and conclusions haven’t been published in a peer-reviewed journal, so they must be considered preliminary. And the five-year survival rate was significantly different between patients who had only a mastectomy or lumpectomy, regardless of their hormone receptor status.

Patients treated with BCT (lumpectomy plus radiation) showed an unadjusted five-year overall survival of 96 in 100. The rate for the mastectomy patients was 90 in 100. Among women who had no radiation, only breast-conserving surgery (BCS) the rate was 87 in 100.

Dr. Catherine Parker and her colleagues at the MD Anderson Cancer Center in Houston analyzed how the choice of treatment affects survival according to each tumor’s biology. The analysis involved 16,646 patients newly diagnosed with stage I breast cancer who were treated in 2004 and 2005.

More than 11,200 were treated by BCT, 3,587 by mastectomy and 1,845 by BCS. The mean age was 59 in the BCT subgroup, 62 in the mastectomy group and 66 in the BCS group. The follow-up period was nearly seven years.

Tumors were classified by hormone receptor status — HR+ was positive for receptors for estrogen, progesterone or both, and HR- was negative for both types of hormone receptors. The primary outcome was overall survival.

The study made two key points, according to Dr. Harold Burstein of the Dana-Farber Cancer Institute in Boston. One confirms many previous studies showing that in terms of survival, BCS is at least as effective as mastectomy. Two is that the combination of radiation and lumpectomy is very important for overall survival.

Burstein told MedPage Today that the second take-away "has been a controversial point. The benefits in some of the studies have been rather small.

"What's clear in this population-based study of thousands of women is that adding radiation therapy — even for the favorable-prognosis stage I breast cancers — helps women do better in terms of survival down the road."

We would add that any time you can avoid a more invasive procedure in favor of a less traumatic surgery, such as lumpectomy over mastectomy, you reduce your risk of complications, such as infection, and also the psychological fallout from losing part of your anatomy.

To learn more about breast cancer, see our backgrounder.

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September 14, 2014

DEA Will Allow Consumers to Return Unused Prescription Drugs

The federal government is finally addressing this country’s serious abuse of prescription drugs with more resources than just those that regulate health care. The Drug Enforcement Administration (DEA) has agreed to allow consumers to return unused prescription drugs to pharmacies to improve the chances that they won’t be used except for what they were intended for.

As reported last week in the New York Times, of most concern are drugs classified as controlled substances, such as opioids (painkillers) including OxyContin, stimulants including Adderall and depressants including Ativan. The DEA wants to reduce unneeded medicines that are ripe for abuse by the patients’ family, or stolen for resale on the street.

As we’ve blogged, injuries and deaths from dangerous drugs, especially opioids, have risen sharply in recent years, and as The Times noted, more than 7 in 10 teenagers say it is easy to get prescription drugs from their parents’ medicine cabinets.

The new regulation permits patients and their relatives to deliver or mail unused prescription meds to authorized collection centers in packaging that will be available at pharmacies, senior centers, libraries and other public locations. It’s supposed to go into effect next month.

Until now, it was illegal to return drugs — the Controlled Substances Act permitted only patients to dispose of the drugs themselves, or turn them into law enforcement agencies. Twice a year, the DEA sponsored a national “take back” event for people to return drugs anonymously to local police departments, sort of like the gun buy-back programs some communities sponsor, and in the last four years, according to The Times, 4.1 million pounds of prescription medications have been turned in.

But there’s plenty more where they came from: About 3.9 billion prescriptions were filled at pharmacies last year, according to the Kaiser Family Foundation.

The semi-annual events removed only “an infinitesimal fraction of the reservoir of unused drugs that are out there,” Dr. Nathaniel Katz told The Times. He teaches at the Tufts University School of Medicine in Boston and studies opioid abuse. “It’s like trying to eliminate malaria in Africa by killing a dozen mosquitoes.”

But Katz hopes the new effort will have a bigger effect. Having drop-off receptacles for controlled substances in pharmacies offers unlimited disposal opportunities.

Of course, people can always flush medicine down the toilet, or dispose of it in the trash, but those habits are discouraged because of environmental concerns.

Some observers warn that because the program is voluntary there’s no guarantee that a sufficient number of venues will establish take-back programs or set up collection receptacles to make a difference, and that other obstacles might arise.

Police departments, for example, often incinerate the illicit drugs they seize, but a local pharmacy might not be able to do that. So their collections would arrive solely by mail, which is probably asking a lot of consumers these days. Also, who pays for the disposal — communities, pharmacies, insurance companies, patients or pharmaceutical companies — isn’t addressed in the DEA’s new rule.

We believe that because the pharmaceutical companies make the profit on these dangerous products they also should bear the costs of removing them in order to minimize their harm when used inappropriately. Is anyone surprised that they’ve objected to this idea? (See our blog, “Drug Companies Oppose Requirements to Take Back Unused Medicine.”)

MedReturn manufactures steel boxes used by police stations in 49 states to collect prescription drugs. Some people worry about their security, because if they “are available to the public, they have to be under law enforcement eyes, because they are gold at the end of the rainbow for someone with an opioid addiction,” Gary Tennis, secretary of the Department of Drug and Alcohol Programs in Pennsylvania, told The Times. His department has 200 MedReturn boxes and plans to install 100 more.

And last year, the American Pharmacists Association told the DEA it was concerned that pharmacies could be held legally liable if a secure drug drop-off receptacle was broken into and its contents stolen. It cautioned that in such uncharted legal waters, pharmacies might be reluctant to participate in a disposal program.

But the biggest obstacle to getting people into the habit of disposing of their unused and unneeded drugs is the understanding that it’s irresponsible to do otherwise.

Still, the new DEA regulation, Dr. G. Caleb Alexander told The Times, “is big news and long overdue.” He’s co-director of the Center for Drug Safety and Effectiveness at Johns Hopkins Bloomberg School of Public Health. “It’s baffling that it’s so easy to get a prescription for opioids and yet so difficult to dispose of these drugs safely.”

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September 11, 2014

Researcher Is Surprised by Wild Disparity in Cost for Simple Blood Test

File this under “irrational”: At one hospital, a blood cholesterol test cost $10, while another in the same state charged $10,169. That’s a multiple of more than 1,000.

Wildly divergent costs for similar lab tests was the subject of a recent report in the journal BMJ Open, which looked at charges for routine blood tests at California hospitals that were performed in 2011.

The researchers, as noted on, (KHN) found no rational explanation for the dramatic different in listed prices, although they did recognize that teaching hospitals and government hospitals generally charged less than other facilities.

Here’s another blow-you-away comparison: for a basic metabolic panel, another common blood test, the average hospital charged $371, but some charged as little as $35 to as much as $7,303, more than 200 times more.

Dr. Renee Hsia, lead author of the study, and a professor of emergency medicine at University of California, San Francisco, told KHN, “When people try to understand why prices are the way they are, we have no ability to explain it. That is the take-home message. That is what is so disturbing.”

Almost as disturbing, in our opinion, is the response of the California Hospital Association, which dismissed the report as irrelevant and said most patients pay discounted rates because of their insurance coverage. “Charges are meaningless data — virtually no one pays charges,” said Jan Emerson-Shea, the association’s vice president for external affairs.

How arrogant. How clueless. How unhelpful in addressing America’s out of control health-care price management.

Hsia is familiar with the “say-what?” aspect of medical pricing. She once studied listed charges for labor and deliveries, and for appendectomies in California, and found that the former varyied by as much as 11 times, and that charges for a routine appendectomy ranged from $1,500 to $182,955.

Earlier studies by Hsia identified variations in listed charges for labor and deliveries and for appendectomies in California, with labor and delivery charges varying eight to 11-fold between hospitals, and charges for a routine appendectomy ranging from $1,500 to $182,955.

But even she was surprised by the variation in cost for a single line item like a blood test.

“There is always some variation in patients, even among young healthy adults, and there are variations in physician practice,” she told KHN. “But these are very basic, standard blood tests. It doesn’t matter if you’re sick or not, a complete blood count is a complete blood count. You draw the blood, send it to the lab and put it in a machine.”

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September 10, 2014

Seniors: Beware of Drugs That Present a Fall Hazard

The older you get, the higher the probability that you take a prescription drug, or several. What’s supposed to help you, however, can pose a risk — half of the 20 most prescribed medications taken by older people might increase the risk of a fall. And falls in older people can be deadly.

According to a study published in the European Journal of Public Health, antidepressants and drugs taken to control pain were most strongly associated with a greater probability of being injured in a fall. Serious injuries were significantly more common with 11 of the 20 medications studied.

The researchers studied prescription drug data on nearly 7 million Swedes older than 65. They counted the number of falls among people taking any of the 20 medications most commonly prescribed to seniors in Sweden, and identified 64,399 cases of such injuries that led to hospitalization.

The researchers acknowledged that some added risk could result from the conditions the drugs are prescribed to treat. But because the older population is large and growing, they say any association of medication and fall injuries must be considered by doctors. We would add our usual advice: When your doctor prescribes a medication, always ask:

  • Why is this the best treatment?

  • What will happen if I don’t take it?

  • Are there alternatives and/or a generic version?

  • When can I expect to see results?

  • What are the side effects, and how likely am I to experience them?

  • What are the risks?

  • Are there foods or other medicines I should avoid when taking this medicine?

Although this was a European study, more than 40 million people in the U.S. are over 65 years old, as noted on, and 1 in 3 of them take eight or more medications daily, according to the National Center for Biotechnology Information.

“Falls are a leading cause of disability and death among seniors,” Reuters reported, “and researchers increasingly suspect that prescription medications play an important role in fall injuries.”

The Swedish study found that men and women taking opioid painkillers as well as men taking antidepressants were more than twice as likely to have a fall injury as those who weren’t taking those drugs. Women taking antidepressants were 75% more likely to have a fall injury.

Drugs for ulcers and GERD (gastroesophageal reflux disease, for which drugs that suppress stomach acid are prescribed), calcium, vitamin B12 and some nonopioid painkillers also were linked to as much as a 75% percent greater risk of fall injuries. Heart medications, generally, were not linked to fall risk.

As Reuters pointed out, “The study cannot prove that medications caused falls in all cases, and for drugs that have not previously been linked to fall injuries — including anticlotting agents, drugs for peptic ulcers and vitamin B12 — the researchers think the underlying conditions the drugs are prescribed to treat may be to blame.”

Telling the difference between a fall resulting from a disorder and one caused by medication can be difficult. Dr. Johan Fastbom, a professor at the Aging Research Center at the Karolinska Institute told Reuters that people should “[pay] attention to other symptoms caused by the drugs.” They include vertigo, dizziness, drowsiness, psychomotor impairment, muscular weakness and cognitive impairment.

Anyone who takes medication and experiences any or several of these symptoms should discuss with their doctor if the risk is greater than the benefit.

Further studies probably will examine how different doses of these medications affect both treatment outcome and fall risk. Doses often vary considerably and often are different for men and women.

Researchers also probably will study potential interactions among medications, including those taken over the counter.

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September 8, 2014

Surgery Often Doesn’t Work on Worn Out Knees

As they age, a lot of people have knee pain from osteoarthritis, and a lot of them undergo arthroscopic surgery to relieve it. But several studies find that the procedure offers neither improved function nor less pain for many.

A meta-analysis — one in which the data from many different studies are crunched — published in the journal CMAJ looked at how effective the surgery is to repair degenerative meniscal tears in patients with mild knee osteoarthritis.

Osteoarthritis is the most common form of arthritis. It occurs when cartilage and other tissues in the joint degenerate, leaving the bones with less cushioning and flexibility. Associated with middle and older age, it causes pain and stiffness, and is especially common in hip, knee and thumb joints. The meniscus is the cartilage, or shock absorber, in the knee joint.

As explained by, many patients with knee osteoarthritis (OA) also have degenerative meniscal tears. Previous studies have shown that arthroscopic surgery offers little benefit for people with severe arthritis, but what it does, or doesn’t do, for people with milder cases was unclear.

Arthroscopic surgery is less invasive than traditional surgery. It both diagnoses and treats problems. It uses smaller incisions and introduces a slender “scope” to view the damage and repair it. Traditional surgery involves larger incisions and more disruptive tools.

Arthroscopic surgery offers less risk for complication (such as infection) and a faster recovery time. But, of course, all surgery has some risk.

The CMJ researchers compared 805 surgical patients with people whose condition was managed without an operation. The surgery patients’ average age was 56, and they all had degenerative meniscal tears.

Knee function was measured on a scale for which 10 denoted “minimal important difference.” At six months after surgery, the patients’ average score was 5.6. Their measure for pain was even less.

The analysis involved seven trials. Five looked at function as long as two years after the procedure, and they found scores that did not meet the threshold of minimally important difference to patients.

Three trials considered long-term pain, and found no improvement in pain scores.

“The [minimally important difference] is the smallest effect that an informed patient would perceive as valuable enough to justify a change in therapeutic management when weighing the anticipated benefits against the possible harms of an intervention,” the researchers reported.

Although the researchers called for more studies to look at factors such as body mass index (if patients are overweight and, if so, to what degree) and how long individuals have suffered with symptoms, and to what degree, they still called this analysis “moderate evidence” of little benefit for surgery in mild OA.

“In the context of limited healthcare resources, clinicians must carefully select patients with degenerative meniscal pathology who would benefit from surgical intervention,” they wrote.

But because it’s not clear who those people are, it’s probably best to treat your knee OA, at least at first, with less invasive, rather than surgical, approaches. (See our blog from early this year, “Common Knee Surgery Should Probably Be a Last Resort.”) That means, possibly, physical therapy, weight loss (if necessary) and judicious use of over-the-counter anti-inflammatory drugs, if advised by your doctor.

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September 7, 2014

Robotic and Traditional Bladder Surgery Show Similar Rate of Complications

For all its techno-wonder and new-age appeal, robotic surgery has racked up a host of problems, including unacceptable incidents of tears and burns to internal organs. Now, a new analysis of robotic versus traditional methods showed no difference in the rate of complications for surgical removal of the bladder.

Robotic surgery is a minimally invasive procedure in which surgeon-controlled instruments work in smaller spaces (and with smaller incisions) than traditional, or “open,” surgery. It’s used for a range of disorders involving the prostate gland, uterus, gallbladder and heart valves. In addition to an alarming number of adverse outcomes, training for robotic surgery has been shown to be deficient, and it’s also more expensive.

Hospitals and surgeons, with an investment in the equipment, want to use it as much as possible to justify the cost, but that could conflict with what’s best for the patient.

The recent study, published in the New England Journal of Medicine, (NEJM) looked at robot-assisted cystectomy, a procedure that removes the bladder, for 118 patients with invasive bladder cancer. They all shared similar baseline characteristics. According to MedPage, it was one of the first randomized comparisons of open versus robot-assisted surgery.

According to the U.S. Department of Health and Human Services, bladder cancer is the fourth most commonly diagnosed cancer in men and 10th most commonly diagnosed cancer in women in the U.S. It’s estimated that more than 72,000 people will be diagnosed with new cases of bladder cancer this year, and that more than 15,000 will die from it.

In the NEJM study, 90 days after surgery, 62 in 100 people who underwent robotic surgery had complications; 66 in 100 who had open surgery did. Complications defined as “severe” also showed comparable rates.

There were some qualifications: Surgeons using one method were different from those using the other, so one doctor’s technique couldn’t be compared exactly with another’s. All of the surgeons were experienced in their techniques, and all surgeries were performed at Memorial Sloan Kettering Cancer Center in New York.

As the researchers wrote, "Because the trial was performed by experienced surgeons at a single, high-volume referral center, the results may not be generalizable to all clinical settings. Nonetheless, these results highlight the need for randomized trials to inform the benefits and risks of new surgical technologies before widespread implementation."

Cystectomy is the standard of care for nonmetastatic, invasive bladder cancer. “Invasive” means that the tumor has invaded at least the lining of the bladder; “nonmetatstatic” means the cancer has not spread beyond the original site.

Even though removal of the bladder is standard for these patients, it often leads to complications. Patients most likely to experience them are older and have other diseases. The recovery period generally is long.

Earlier studies, reports MedPage Today, suggested that the robot-assisted cystectomy resulted in fewer complications and a shorter hospital stay compared with open surgery but data from randomized trials — the most scientifically sound — were lacking. And a recent report that looked at results internationally showed that almost half of the patients who had the robotic procedure experienced complications within 90 days.

So the NEJM researchers devised a randomized clinical trial to compare open with robot-assisted laparoscopic cystectomy in patients with newly diagnosed invasive bladder cancer. Four surgeons performed all of the open cystectomies, and three did the robot-assisted cystectomy operations for the patients randomly assigned to either group.

In addition to patients in the robotic surgery group experiencing similar rates of complication to the open surgery patients, their stay in the hospital was no shorter — both groups averaged eight days as an inpatient.

Dr. Daniel Barocas told MedPage Today, "The investigators are really to be commended for undertaking this; this is a hard thing to do. The patients are to be commended for trusting their doctors enough to undergo a procedure that is not yet proven to be comparable to the traditional approach."

And as important as the study is, remember that it evaluated only one outcome of these surgeries — complications. Further studies are required to understand other important outcomes, including cancer control and return to work or to routine activities. As Barocas noted, cystectomy is a major operation, regardless of which technique is used. So a lot of people undergoing it can be expected to experience complications.

Still, if you are facing this procedure, find out all you can about not only the risk factors of each method, but the financial interests of the facility and the practitioners with regard to the possible use of robotic equipment. You can’t make an informed choice if you don’t have all the relevant information.

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September 4, 2014

FDA Falls Asleep in Reporting Faulty Surgical Device

The FDA’s Medwatch program is supposed to enhance patient safety by publicizing adverse medical events, but you have to wonder how effective it is when the feds wait more than four months to post a serious problem with a medical device.

Although a recall was issued in mid-April for a faulty jaw implant, it wasn’t until the end of August that the public learned about it on MedWatch.

The surgical device, known as a Craniomaxillofacial (CMF) Distraction System, is used to correct jaw defects. It’s made by DePuy Synthes, which sent its customers an “urgent notice” April 16.

Used in pediatric and adult patients to correct birth defects, or those that occur as a result of trauma, apparently CMF can become unstable, and reverse direction after surgery.

It was a Class I recall, which is the most serious level, defined by the FDA as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

And it took more than four months for us to learn about it?

The FDA said infants are at the highest risk for injury if the device fails, but all patients are at risk, and could need additional surgery to replace a failed implant. So far, 15 reports of injury have been associated with the use of the device.

If you have questions or concerns about the device, call DePuy at (800) 479-6329. You can also file a report with MedWatch … for what that’s worth.

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September 3, 2014

Harms Usually Exceed Benefits of Cancer Screening for Older People

Minimal benefit in exchange for considerable cost, discomfort and the possibility of complications -- clearly that's a losing proposition, but that is exactly what’s happening with cancer screenings and people over age 65.

A study published in JAMA Internal Medicine looked at screening rates for four types of cancer. Each rate declined as a patient's mortality risk increased, but as many as 55 in 100 patients with a high mortality risk continued to be screened for prostate, breast, cervical and colorectal cancers. And the inappropriate use of screening tests, such as Pap tests for women who had undergone hysterectomy, also was apparent.

"A substantial proportion of the U.S. population with limited life expectancy received prostate, breast, cervical, and colorectal cancer screening that is unlikely to provide net benefit," the researchers concluded.

The harm of such overtesting, the researchers said, is that people at high risk of mortality spend money they needn’t, and are exposed to the risks of invasive procedures.

The analysis involved 27,404 people age 65 and older.

A second study, also in JAMA, showed that if practitioners shortened the time between colonoscopy screenings for colon cancer from 10 years to five, the improvement in quality of life would be minimal, and that it would cost more than $700,000 for what is known as a QALY — a quality-adjusted life year.

“A consensus exists within the medical and scientific communities,” reported, “that routine cancer screening is unlikely to benefit people who have limited life expectancy. The consensus is reflected in clinical guidelines and more recently in the American Board of Internal Medicine Foundation's Choosing Wisely program.”

Choosing Wisely is an initiative of medical professionals who want to help patients decide on care that is supported by evidence, that doesn’t duplicate other procedures they’ve had, isn’t harmful and is truly necessary. We’ve written about Choosing Wisely many times (here, here and here), and not always (but often) in glowing terms.

These studies reinforce its best motives.

The researchers wanted to see how well the “consensus” was put into practice. In the first study, they used data from the National Health Interview Survey (NHIS) collected during interviews conducted from 2000 to 2010. One main objective was to compare clinical practice with the Healthy People 2020 goal to promote evidence-based use of cancer screening. Healthy People is a federal government effort that provides science-based, 10-year national objectives for improving the health of all Americans.

The NHIS survey participants answered questions about cancer screening. Breast cancer screening was defined as a mammogram within the last 2 years, cervical cancer screening as a Pap test within the last 3 years, colorectal cancer screening as any screening test (colonoscopy, flexible sigmoidoscopy, or fecal occult blood test) within the last 5 years, and prostate cancer screening as a prostate specific antigen (PSA) test within the last 2 years.

The nine-year mortality risk was calculated for each patient/participant. The estimates factored in age, gender, smoking status, body mass index (overweight/obesity status), comorbidities (the presence of two or more coexisting medical conditions or disease processes), hospitalizations, perceived health and functional measures.

A low risk of dying within 9 years was defined as less than a 1 in 4 chance; intermediate risk was 1 to nearly 2 in 4; high risk was 1 to nearly 3 in 4; and very high risk was a greater than 3 in 4 chance.

By those measures, 8,263 participants had a low risk of death within nine years, 8,655 an intermediate risk, 6,263 a high risk and 4,223 a very high risk.

The older patient population was composed of 87% whites. Slightly more than 4 in 10 were married, 99 in 100 had health insurance, and 96 in 100 had a consistent place where they received health care. Their educational and geographic backgrounds were diverse.

The screening rates by type of cancer and mortality risk (low to very high) were:

  • prostate: 64 in 100 (70% to 55%)

  • breast: 63 in 100 (74% to 38%)

  • cervical: 57 in 100 (70% to 31%)

  • colorectal: 47 in 100 (51% to 41%)

Because some clinical guidelines go by age rather than life expectancy, the researchers also crunched the numbers by patient age. They showed that screening rates for breast cancer were 55 in 100 for patients older than 75 and 72 in 100 patients younger than 75; cervical cancer rates were 56 in 100 for women older than 65 and 3 in 4 if they were younger; colorectal cancer screening rates were 3 in 10 for patients older than 85, 46 in 100 for patients 75 to 84 and 1 in 2 for patients younger than 75.

The age analysis didn’t include prostate cancer screening because, as we’ve blogged, the United States Preventive Services Task Force recommends against routine PSA screening at any age.

Cervical cancer screening with a Pap test also was analyzed in the subgroup of women who had a hysterectomy for benign conditions (that is, problems other than cancer). Screening rates were 56 in 100 for low-risk patients, 45 in 100 for intermediate-risk patients and 1 in 3 for women who had a high mortality risk.

An increased mortality risk was associated with a reduced likelihood of screening for all but colorectal cancer. Older age was an independent predictor of a reduced likelihood of screening for all cancers. Married participants and those with higher education, insurance coverage or a consistent place for receiving health care had an increased likelihood of being screened for cancer.

The researchers said that it was tough for clinicians to assess someone’s 10-year life expectancy, so screening guidelines were “impractical” to determine a doctor’s adherence to a certain standard.

But one thing is clear: Although screenings decrease as patients age, they’re still awfully common, despite proven benefit.

The second study focused on colorectal cancer screenings using colonoscopy, in which the doctor inserts a thin, flexible tube into the rectum and up into the lower intestine to view the lining of these organs. The study subjects were 65-year-old Medicare beneficiaries with an average risk of colorectal cancer. At 55 years old, they had received a colonoscopy that was negative.

Researchers compared clinical-guideline recommendations (colonoscopy at 65 and 75) with a more frequent interval of every 3 to 5 years. They measured QALYs gained, additional colonoscopies per QALY gained and additional costs per QALY gained.

Compared with no screening, guideline-based screening colonoscopy prevented 14 cases of colorectal cancer and 7.7 cancer-specific deaths. It resulted in about 63 life years gained per 1,000 beneficiaries screened. Screening at a five-year interval led to prevention of only an additional 1.7 cases of colorectal cancer and 0.6 cancer deaths. The gain of life years per 1,000 beneficiaries screened was only 5.8.

"To achieve this relatively small added benefit, 783 additional colonoscopies had to be performed, causing 1.3 additional complications," the authors wrote.

A three-year screening interval testing people as old as 85 prevented even fewer cancers and cancer deaths. And the life years gained per 1,000 patients screened were fewer, too.

In a commentary accompanying the JAMA studies, Dr. Cary P. Gross of Yale University School of Medicine said that the results support the view that "cancer screening in the 21st century ... is losing its luster.”

"It is particularly important to question screening strategies for older persons," he wrote.

"Patients with a shorter life expectancy have less time to develop clinically significant cancers after a screening test and are more likely to die from noncancer health problems after a cancer diagnosis."

He called for patient information that helps them understand the benefits and harms they can expect from a cancer screening, based on their individual health profile. He also said the medical community should develop quality measures to address the overuse of screening tests.

We’ve been saying that for years.

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September 2, 2014

Exposè Shows Military Hospitals Are Huge Providers of Substandard Care

In a sweeping and horrifically detailed indictment, the New York Times called out the U.S. military hospital system for its shockingly substandard care.

The paper looked at the records of the 40 hospitals across the country run by the armed forces that provide care for 1.35 million active-duty service members and their families, among other patients. The problem of poor care appears to stem from the fact that these hospitals are so small and see so few patients that doctors and nurses don't get enough experience to diagnose and treat serious illnesses properly. Most of these facilities handle less than one-third as many patients as a typical civilian hospital.

These numbers are so significant that Dr. Lucian L. Leape, a leading patient-safety expert at the Harvard School of Public Health, said, “I think they should be outlawed.”

Another huge problem is one of priorities: Hospitals that must develop practitioner skills to address battlefield casualties don't have the resources (or will) to hone the skills necessary for a typical hospital caseload of primary and specialty care, such as delivering babies and performing routine surgeries.

Some people who worked at military hospitals question whether, in most cases, the military should even be in the hospital business.

“It’s a dangerous game,” John Schafer told The Times. He served for eight years as deputy commander for clinical operations at Reynolds Army Community Hospital at Fort Sill in Oklahoma. Now he's senior director of physician services at Comanche County Memorial Hospital nearby. From his office, he can see the military hospital, which treats an average of just 13 patients a day.

“I loved that place,” he said. “But it should not be a hospital. I retired because I could see the unsafe care. Nobody was listening.”

In The Times' analysis, the biggest problems at military hospitals were found in maternity care and surgery. "Compared with leading civilian hospitals, more than half of domestic military hospitals," the paper reported, "... performed poorly on one or more measures of harm to mothers or babies in 2011 and 2012. ... half of the military hospitals whose surgical data are submitted for outside review had higher than expected rates of surgical complications."

Among the patients whose suffered from military hospital deficiencies:

  • a woman who had what was supposed to be a routine hernia surgery but ended up having more than a dozen follow-up operations to address complications that have left her in constant pain, and without a stomach, a job or anything resembling her former life;

  • a woman who went in for a checkup during her high-risk pregnancy during which nurses lost track of the fetus' heart rate for nearly an hour, failed to recognize the emergency and the fetus died. The parents sued for malpractice and received a judgment of $250,000;

  • a 7-week-old baby died of congestive heart failure because of what appeared to be delays and malfunctioning equipment at a hospital where one of its doctors told The Times, “People notice that something is wrong, and they are told to mind their own business.”;

  • an active-duty servicewoman died after medical workers missed the signs of necrotizing fasciitis, a dangerous bacterial infection;

  • a retired officer died of appendicitis two days after being told he had a hernia.

And that's only a sampling.

Would you send a loved one to a military hospital where even its own medical staffers say, “If you are a physician, it’s very scary. You decide you are going to admit your sick patient, but there is no I.C.U., no gastroenterologist, no pulmonologist, no pathologist. Nobody’s on call.”?

As The Times reported, last year the government paid 21 military patients more than $500,000 each to settle malpractice claims, an indication of “significant harm.”

To learn more about military malpractice, see our backgrounder.

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September 2, 2014

Court Nixes Litigation Standards Set by Pathologists

What if a truck drivers' union tried to set standards for when juries could conclude that a driver was negligent in causing a motor vehicle wreck? Or what if a trucking company could defend its driver falling asleep at the wheel by showing that its other drivers had impeccable driving records?

That's about the situation the courts face with litigation guidelines set by two pathologists' groups about when misreadings of Pap smears by members of these groups should be judged negligent.

A recent ruling by the 11th Circuit Court of Appeals, the federal appeals court for the southeastern-most states, found the pathologists were wrong in trying to enforce their litigation standards. And it reinstated a lawsuit brought by a patient which had been thrown out by a trial judge because the plaintiff's expert had not followed the litigation guidelines promulgated by the College of American Pathologists (CAP) and the American Society of Cytopathology (ASC).

Here's a quotation from the 11th Circuit's decision in Adams v. LabCorp that shows the judges saw the difference between clinical practice guidelines promulgated for better patient care versus these litigation guidelines:

As an initial matter, it is important to put these guidelines in context. Both sets of them focus not on how cytotechnologists should go about their duties in examining slides, but instead on how courts should go about their duty to adjudicate claims against cytotechnologists and similar professionals. In the words of the guidelines, they are to be used in assessing Pap smear slides “in conjunction with litigation or potential litigation.” They are not objective, scientific findings; they are not guidelines followed by laboratories to screen for pre-cancerous or cancerous cells; they are policy proposals to limit how the courts can find the members of the organizations liable for professional negligence when they are sued.

As far as we are aware, this is the first time that an industry group has promulgated a set of guidelines that attempts to define and limit the evidence courts should accept when the group’s members are sued. The members of the CAP and ASC have a substantial interest in making it more difficult for plaintiffs to sue based on alleged negligence in their Pap smear screening, and their guidelines do just that.

The guidelines, if enforced, would have made it not just difficult, but VERY difficult to impossible, to prove that a laboratory had been careless or negligent in reading a patient's Pap smear. Here's an excerpt from the ASC's guidelines:

A violation of a reasonable prudent practitioner standard of practice based on how specific Pap tests were screened and interpreted can only be established through an unbiased blinded rescreening review process that includes the contested case as one of a number of normal and abnormal GYN cytology samples representing a variety of disease states. Focused review or review with knowledge of subsequent development of carcinoma inevitably biases the objectivity of the review against the laboratory and does not reflect standard practice.

Hindsight bias is an issue, and every honest expert witness I've dealt with tries to make sure to keep that in mind and not let it unduly influence his or her view of a case. But these guidelines essentially use an elephant gun to go after a flea.

In practical terms, the ASC guidelines would require the plaintiff to hire an independent pathologist to go to the defendant laboratory, whereupon the pathologist would be put to a test devised by the defendant: the specimens at issue would be salted in with a group of other specimens, some normal, some not, and the pathologist would then study the specimens under the microscope as if they were specimens seen in the ordinary course of lab work.

(Except, of course, that most labs, LabCorp included, use "cytotechnologists," non-doctors, to first screen the specimens and point out potential abnormalities for the pathologists to then study more closely. And the issue in this case was that the cytotechnologists at LabCorp had not even flagged this patient's smears as possibly worrisome.)

And what if the independent pathologist passes the test devised by the defendant lab and correctly diagnoses the mix of normal and abnormal specimens? The test of the plaintiff's expert is still not over, because the ASC guidelines go on to say:

Courts and experts should recognize that a false‐negative result by itself is not sufficient proof of negligence. Rather, the courts should evaluate whether the overall Pap‐test practices of the laboratory meet the standard of care and whether unbiased blinded rescreening consistently detects significant abnormalities not initially identified by the laboratory.

I've italicized two key pieces. First, "overall practices of the laboratory" seems to mean that as long as the lab overall has a good track record, it shouldn't be found negligent for messing up on one patient's specimen, even if it was wrong that one time. This would be like a trucking company saying, "Never mind that our driver fell asleep at the wheel; we have a nearly spotless driving record other than this one time."

A fundamental aspect of American tort law is that the defendant's conduct is judged on the specific case, and it's not relevant to prosecute or defend a case based on what happened on some other occasions (with a few exceptions when the allegation of wrongful conduct is that the defendant had failed to detect a pattern in the prior events). This prevents plaintiffs from using prior bad events unfairly, and it prevents defendants from using prior good events unfairly.

The second italics is on the word "consistently." That means the pathology groups want their members to be found guilty ONLY if no experts can be found to defend their reading on a particular occasion. So only the most egregious cases could go forward, since it's child's play to find an expert who will give a pass to conduct that other experts will criticize.

In the Adams case, the plaintiff had hired an expert of sterling credentials, Dr. Dorothy Rosenthal of Johns Hopkins Hospital. She had not only spent 40 years training cytotechnologists how to read Pap smears, she also had worked on the pathologists' committee that set the medical standards for when cells on a Pap smear look cancerous, when they look borderline, and when they are benign.

The lab had criticized Dr. Rosenthal for doing a non-blinded review of Ms. Adams' Pap smears, but as the 11th Circuit pointed out, the lab's own expert witness did exactly the same non-blinded review. And the 11th Circuit was troubled by the one-sided nature of the litigation guidelines:

...the ASC's guidelines condemn non-blinded review because it “biases the objectivity of the review against the laboratory,” but express no concern about non-blinded review biasing the assessment of defense experts against plaintiffs. Clearly, the purpose of the guidelines is to raise the bar only on the plaintiffs' side of the courtroom.

The litigation guidelines go way too far on hindsight bias, as the court observed:

...both sets of guidelines treat the mere risk of review bias as intolerable. They do not specify the frequency or degree to which review bias actually affects reviewers’ judgments. Nor do they cite any empirical evidence supporting their assertion that knowing the outcome “inevitably biases” the reviewer. Yet they insist that a court should exclude expert testimony unless the expert has eliminated entirely the possibility of any review bias. That would be a radical reworking of [Federal Evidence] Rule 702, which requires courts to determine that the expert’s method is reliable, not that it is free of any possibility of bias.

The lab also claimed that Dr. Rosenthal's opinions were "Ipse Dixit" -- Latin for, "because I say so" -- but the Court said that was wrong too, since the expert had used the same atlas showing what abnormal cervical cells look like that the defendant's employees had used:

Dr. Rosenthal used a well-established classification system to assess the cells: the same Bethesda System that LabCorp's cytotechnologists use. In her deposition testimony she went picture-by-picture, pointing to specific places in each one where Ms. Adams's cells showed abnormalities and classifying those abnormalities using the same Bethesda classification system that is used by LabCorp's cytotechnologists and nearly every other professional in the field of cytopathology. And the Bethesda Atlas, which is maintained by the ASC, provides numerous examples of each abnormality that Dr. Rosenthal identified, including “classic examples” of abnormal cells as well as “borderline” cells. As Dr. Rosenthal explained in her deposition, the images in the Atlas could be used to assess whether her opinion was in step with the established standards in the field. The fact that Dr. Rosenthal applied an established diagnostic system in which she was well versed contributed to the reliability of her methodology.

One puzzle remains: these guidelines have been around since at least 2000, in the case of ASC, but only now in 2014 reached the attention of a federal appeals court. Maybe that's because trial courts before the one that was reversed here by the 11th Circuit could see so plainly that the "litigation guidelines" were an improper attempt by a self-interested professional group to stack the deck of lawsuits against its members.

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