DC Medical Malpractice & Patient Safety Blog

Cosmetics Can Help You Look Good But Feel Bad

Thu, 17 May 2012 12:32:58 -0500

Beauty’s only skin deep, they say, but ugly cuts to the bone.

And by “ugly” we’re talking about the potential for cosmetics to have unattractive consequences. At least that’s the thinking behind the push for more accurate product labeling on makeup, sunscreen, bath and other personal products.

As explained in a story by the Detroit Free Press, the chemicals, minerals and unknowns that are constituents of these lotions and soaps and hair applications do not undergo routine review by the FDA or USDA or any other regulatory agency. Only when consumer problems necessitate attention are these products scrutinized.

Between the fundamental human desire to look good and the overwhelming marketing hype characteristic of the cosmetics industry, consumers are hard-pressed to get accurate, helpful information about the ingredients with which they have such a close, personal relationship.

That’s not acceptable to U.S. Rep. John Dingell, D-MI. He’s conducting the first congressional hearings in decades about cosmetics safety. Several pieces of legislation have been introduced to give the FDA the power to register cosmetics and enable recalls if products prove unsafe.

Last year we wrote about one risky product, Brazilian Blowout, a hair-straightening formula that was found to contain dangerous levels of formaldehyde. Consumers suffered respiratory problems and skin rashes, and now Brazilian Blowout labels carry a warning. But it’s still a legal product and the FDA has no further authority to regulate it.

Lack of research into the long-term effects of low-level exposure to cosmetic chemicals makes clear harm uncertain. In the cosmetics industry, according to the co-founder of a cosmetics company quoted by the Free Press, "everyone's intentions are safe levels. But then, everyone is using 20 products a day. It's this geometric explosion of chemicals in our lives. ... It's not one thing."

"The question is whether the occasional application on the skin is really dangerous," said Dr. Scott Ramsey, director of the Cancer Prevention Program at the Seattle-based Fred Hutchinson Cancer Research Center.

Years ago paraben -- a preservative used in cosmetics and deodorant – was suspect in breast tumors. People dumped these products, but it’s still unclear if paraben is harmful. Preservatives prevent the growth of harmful bacteria in a product that sits on a bathroom shelf or at the bottom of a purse, and it’s impossible to completely escape exposure to toxins. Even antibacterial soap, a product that’s supposed to confer protection, has been host to a chemical suspected of causing hormonal issues.

But consumer safety advocates at least want to cut down on exposure you can control. One salon customer interviewed by the Free Press put it concisely: "Better health is not a science problem; it's an information problem."

Don’t use a product without reading the label. If ingredients are not listed, Google the manufacturer for more information or opt for a product you can vet. Search for information about the safety of a given product on the Consumer Products Safety Commission’s Safer Products (CPSC) site.

If a product causes problems—anything from minor skin irritation to more serious issues such as swelling or breathing problems—contact the FDA’s cosmetic topics website, the CPSC and the manufacturer.

If you want the federal government to improve cosmetic product oversight, contact your congressional representative.

Psychiatric Patients Get the Short End of the ER Stick

Tue, 15 May 2012 12:50:40 -0500

The hospital’s emergency room is filled with patients representing a range of urgent problems. The kid with a broken ankle, courtesy a bumpy slide at second base. The woman wearing dark sunglasses and cradling her migrained head. The guy pressing a towel into the web of his hand to stanch the blood from a knife meant to cut a bagel. The hyperactive, foot-tapping college student who alternates between nonstop chatter and low, howling moans, in the throes of an anxiety attack, schizophrenia or who knows what.

Who will be seen first, who will get treated quickly, how long will it take to admit someone who should be an inpatient?

This is a hypothetical example. But it’s pretty certain not to be the patient with the mental disorder. A study published in the Annals of Emergency Medicine showed people presenting at hospital emergency departments and trauma centers with psychiatric problems spent more than 11 hours in the ER, and that they wait even longer if they must be transferred for admission.

If the psych patient is older, intoxicated or uninsured, according the study, the wait is even longer. The time doubled if the patient was discharged not home but to an outside facility.

As reported on MedPageToday, the conclusions highlight how interrelated is mental health care, and how much room there is for improvement for to coordinate care.

This isn’t news. National Center for Health Statistics showed that the average wait for mental health services in an emergency department was 42 percent greater than the wait for other health issues.

In a survey by the American College of Emergency Physicians, 40 percent of emergency department medical directors said psychiatric patients waited more than eight hours from disposition decision to discharge from the ED. Only 7 percent of the directors said medical patients had to wait that long.

In addition to being inconvenient and distressing, waiting too long in an ER can be harmful. See our post, “ER delays cause patients to skip care.”

Some ERs are better able to process psych patients than others.

"Emergency departments (EDs) that are embedded within a larger system of care and have ready access to various levels of after care options,” the researchers wrote, “are likely to be better positioned to more rapidly transition patients through the ED."

There’s still not much authoritative data about just how much psychiatric patients are penalized in the ER because their disorder isn’t visible or exciting or … what? So the latest research was aimed at identifying patient-related and clinical management factors associated with longer ED waits.

Psychiatric patients seeking emergency consultation at five urban hospitals—two academic and three community—were studied. More than 1,000 patients were included. The median age was 39, and the gender representation was equal. About 7 in 10 were non-Hispanic white; two-thirds had public insurance; 13 percent were homeless.

The most common complaints were depression or anxiety (37 percent) and suicidal thoughts or nonlethal self-harm (33 percent). One in 3 showed evidence of alcohol use, with or without other drugs.

On discharge, the most common diagnoses were mood disorder (69 percent) and substance use disorder (41 percent). Nearly 300 patients were discharged to home and nearly 600 were admitted to the hospital or transferred to a psychiatric unit.

The average wait times and average added times were:

transfer outside the care system, 15 hours;

transfer within the system, 12.9 hours;

transfer to psychiatric unit in hospital, 11 hours;

age: 12.6 hours for ages 60 and older, 11.9 hours for ages 41 to 59, 10.7 hours for ages 18 to 40;

positive screen for alcohol, more than 6.2 hours;

diagnostic imaging, more than 3.2 hours;

use of a restraint, more than 4.2 hours;

uninsured, more than 4 hours.

Being admitted or transferred resulted in an additional wait of 3.3 to 7.4 hours. The long wait after diagnosis and before admission/transfer, the researchers said, was the single biggest influence on how long a patient would be confined to care.

"Approximately two-thirds of all patients receiving emergency mental health care … were either admitted or transferred to a psychiatric unit. Although these hospitalized patients tended to be seen and assessed more quickly than patients discharged home, they had significantly longer overall length of stay because of the extended wait time between the decision to admit and the ED discharge."

Glitches on the Path Toward a High Quality Electronic Medical Record System

Mon, 14 May 2012 12:43:25 -0500

Early in 2009, President Obama signed the American Recovery and Reinvestment Act (ARRA). Commonly known as the Stimulus, or Recovery Act, it was intended to juice the sluggish economy, and it reached into all corners of our culture. One of its effects on health care was the establishment of a national electronic medical record (EMR).

Financial incentives were provided for medical providers to transition to electronic record-keeping. Well-designed and well run e-record programs improve efficiency and enhance patient safety, but they require conscientious attention on the part of designers and providers.

One such provider, a cardiologist and a fan of EMR, recently had an experience that prompted him to wonder if electronic record-keeping systems should be considered medical devices, and therefore subject to all the same kind of regulatory oversight given, say, a heart defibrillator.

Dr. Wes Fisher received a medical record from a major medical center that employed an EMR manufactured by a well-established, billion-dollar corporation. As recounted on KevinMD.com, he saw “one of the better examples of how EMRs are contributing to misinformation and confusion when health-care is delivered.”

The report was an internal medicine consultation of a hospital patient whose “medications” portion of the internist’s notes are posted on the KevinMD website exactly as received in the EMR, and identified as “Active Medications.” All told, 55 entries for medications were listed, and Fisher was “terrified."

Some medications were listed multiple times, sometimes with different dosages. Some drugs lacked dosages, such as warfarin, a blood-thinner that must be carefully dosed and monitored. Meds typically prescribed for outpatients are listed along with those typically prescribed for inpatients, making any reviewer of this record unclear what meds this patient is actually taking.

Fisher in no way excuses the internist, or any other doctor, from responsibility over the quality and accuracy of any medical record, whether it’s confined to an office or disseminated to other providers, facilities and insurance companies. But his overriding concern is that when EMRs are poorly developed and/or hospital administrators buy products capable of providing “useless and potentially lethal information about our patients” (his italics), doctors must speak up.

“So how will we measure problems with EMRs?” he asks. “It seems industry representatives would rather not address these concerns. We should ask ourselves, is anyone thinking about this?”

Fisher suggests the creation of an EMR registry similar to the data repository mandated by the Center for Medicare & Medicaid Services (CMS) for implantable cardioverter defibrillators (the ICD Registry). Its purpose would be to track adverse patient outcomes resulting from software systems and would enable EMR manufacturers to learn and improve from everybody’s mistakes.

To learn more about your rights in compiling, keeping and disseminating your medical records, read our newsletter article, “Why Getting and Reading Your Medical Records Can Save Your Life.”

Sunshine Dims with Delay on Big Pharma Payment Reports to Docs

Sun, 13 May 2012 12:23:17 -0500

Here’s another arrow for the quiver of people exasperated with government.

As part of its health-care reform, the Obama Administration proposed that drug companies be made to disclose payments they make to doctors for research, consulting, speaking, travel and entertainment. The rationale, as reported by The New York Times, was evidence that such payments can influence treatment decisions and boost costs by encouraging the use of more expensive drugs and medical devices.

Disclosure, the thinking goes, would make doctors more disposed toward making decisions in the best interests of patients instead of their bottom lines. As we’ve reported, drug and device company largess can be ripe for conflicts of interest.

According to The Times, about 1 in 4 doctors takes cash payments from drug or device makers; nearly 2 in 3 accept routine gifts of meals for themselves and their staff. The Times also concluded that doctors who take money from drug makers often practice medicine differently from those who do not—they’re more willing to prescribe drugs in risky and unapproved ways, such as prescribing powerful antipsychotic medicines for children.

Some companies have begun posting some payment information on their web sites, sometimes as the result of legal settlements with the federal government. Under the new proposal, if a company has even one product covered by Medicare or Medicaid, it must disclose all payments to doctors other than its own employees. The federal government will post the information on a public Web site.

The penalty for noncompliance could be $10,000 for failure to report. A company that knowingly fails to report payments could be subject to a $100,000 penalty for each violation, to a maximum of $1 million a year.

Comments about the proposal were accepted until Feb. 17, then Medicare officials were to issue final rules with the force of law.

Here’s where the archers among us start to take aim. As reported on FDA Law Blog, earlier this month the Centers for Medicare & Medicaid Services (CMS) announced “that manufacturers will not be required to collect data under the physician payment sunshine provisions of the Patient Protection and Affordable Care Act before Jan. 1, 2013.”

The regulation requires the first report to be submitted by March 31, 2013 for payments made in this calendar year, but CMS already has exceeded one deadline--under the Patient Protection and Affordable Care Act (ACA), payment-reporting procedures were supposed to be established by of Oct. 1, 2011.

The postponement gives CMS time to review more than 300 comments about the proposed rule, and also affords manufacturers additional time to prepare for the disclosure reports. Although the CMS didn’t expressly say the March deadline was extended, it’s implicit in the delay.

On news of the extension, Sen. Charles Grassley, R-Iowa, one of the sponsors of the Physician Payments Sunshine Act, said, “It’s disappointing that CMS won’t even collect data at all this year. The process has dragged on long past the statutory deadline for implementation. Consumers need to know more about the financial relationships between their doctors and drug companies sooner rather than later. It’s important that CMS get this right in every way, including the usefulness and accuracy of the information. Given all of the extra time, CMS will have no further excuses for not accomplishing these goals.”

We’d like to believe him. But when it comes to excuses in Washington, supply always
seems to exceed demand.

Getting a Handle on High Deductible Insurance Plans

Thu, 10 May 2012 03:17:28 -0500

What with the uncertainty of the Obama Administration’s health-care reform and the increasing cost of medical care, few areas of U.S. commerce are as volatile as health insurance. But one segment of that industry is decidedly popular, although it’s fraught with “what-ifs.”

In one year, between January 2010 and January 2011, high-deductible insurance plans grew by more than 1 million customers. According to a story aired on PBS Newshour, in collaboration with Kaiser Health News, last year, nearly 3 in 10 workers covered by employer insurance were offered a high-deductible option. Enrollment in such plans has tripled in five years. A survey by the Kaiser Family Foundation (not affiliated with the health-care provider) showed that half of all covered workers in small businesses (as many as 199 employees) had a high-deductible plan.

Deductibles for these plans range from at least $1,200 for an individual to more than $10,000. Before the insurer begins to cover the costs, the consumer must pay the deductible out of pocket. The tradeoff is that the monthly premiums are lower for both employers and consumers than other plans—they average, for an individual, about $1,000-$2,000 a year.

Many employers offering these plans also create health savings accounts (HSAs), a sort of rainy-day fund to which employers and/or employees may contribute money tax-free for use in medical emergencies. The money accumulates year to year, and can be rolled over into a new employer’s plan.

Thanks to the Patient Protection and Affordable Care Act (ACA), even bare-bones, high-deductible plans must cover certain basic, preventive services for free, such as vaccinations. But they’re still risky, even for the young, healthy people for whom they make the most sense.

The PBS story profiled a young ballet dancer who opted for his dance company’s high-deductible coverage. Dennis Adams, in his mid-20s, had never had surgery, had never broken a bone, had never been in an ambulance, had never been to the hospital. He signed up for a $2,500 deductible plan.

Then he tore a knee ligament during a dance performance. The MRI needed to show the extent of the damage cost $1,600, and the provider required that it be paid up front. Adams didn’t have the money.

Lucky for him, the injury was work related, so workers’ compensation insurance covered his cost.

Whether you’re older, infirm or young and robust, high-deductible plans are designed to make you likelier to take care of yourself, and more attentive to how your health-care dollars are spent. In theory, that’s a good thing—the overuse of medical services has fueled an out-of-control medical industrial industry and increased patient harm.

But there’s a black side here, and it’s not just about lacking the cash to cover your deductible.
It’s about the inability for even the most conscientious consumer to price medical services (see Patrick Malone's newsletter this month on "The Unknowable Cost of Medical Care," and what you can do), and the withholding of even needed care. In the PBS story, Dr. Alison Galbraith of Harvard Medical School said that people in high-deductible plans had “a much higher prevalence of delayed or foregone care due to cost” compared with those in more traditional plans.

People are rationing their own care, which is fine for many people who otherwise would overuse the system. It’s not fine if you’re ill or have a chronic condition that can be managed with regular, sometimes minimal care.

One high-deductible plan member allowed as much. “I do get headaches about once a month,” she said, “and they can get really bad. And I still haven't gone to see a doctor about it. … It's like, I'm kind of trying to cheat the system a little bit, because it's like, if I don't go and it's not really serious, then I'm saving money.”

But at what cost?

As Dr. Drew Altman, President and CEO of the Kaiser Family Foundation, put it, “We really need to have a national discussion about whether this is a good thing or this is a bad thing. … I think what it really means is, this is OK for some people if you are pretty healthy. But we have to worry about what these very high deductibles, $2,000, $3,000, $4,000, $5,000 deductibles, is that really even insurance coverage?”

If you’re considering insurance coverage with a high deductible, remember:

Out-of-pocket costs generally include the deductible, the patient's co-pay to see a doctor, prescription medicines and/or hospital costs.

Often, the number of office visits allowed for only the co-pay is limited. If you exceed that number within a calendar year, generally you are expected to pay the caregiver’s out-of-network (or unsubsidized) rate.

HSAs allow beneficiaries to contribute, tax-free, as much as $3,100 for an individual and $6,250 for a family.

The plans are problematic for low-income individuals, especially those with chronic conditions, such as diabetes. People with health problems often have the toughest time meeting the high deductible because their illnesses can keep them from working.

The IRS determines what medical expenses qualify toward the deductible. Recently, the agency dropped over-the-counter medications from its list.

Who Cares If It Works, I Have a Coupon!

Wed, 09 May 2012 13:46:28 -0500

Who doesn’t like a good deal? The popularity of Groupon, the online deal-of-the-hour/day/week service has spawned a whole family of mimics. Unfortunately, suggests Gary Schwitzer on Health News Review, it’s a dysfunctional family when it comes to dubious medical treatments.

In the space of mere days, irresistible deals were available for:

laser toenail fungus treatment;

MRI for “headache prevention screening”;

-lipolaser treatments;

botox;

B12 injections or allergy test.

Never mind that the evidence for lasers eradicating toenail fungus is sketchy, that the claim that an MRI can prevent headaches is positively ludicrous and the lipolaser might be performed by a guy with less training than your dentist.

But Schwitzer was amused most by an offer from Living Social for Colon Hydrotherapy:

“The foliage may be in bloom outside, but if you’re feeling less than fresh inside, today’s deal could help you stem the problem: Pay $35 and get one colon hydrotherapy session (a $75 value). Colon hydrotherapy is a safe, effective method of cleansing the large intestine using water instead of drugs. The gentle infusion of warm filtered water moves naturally through your large intestine, leaving you feeling cleansed and refreshed. The treatment is safe, quick and pain-free. The certified staff uses an advanced state-of-the-art technology to provide you with natural wellness therapies. Don’t be a shrinking violet — nab today’s deal before it goes to seed.”

Commented one guy on the Health News Review site, “Personally, I await the Groupon lobotomy offer…”

Absent pernicious anemia, almost no one needs injections of B12. And no one’s colon is crying out for cleansing. But … got a coupon for hype eradication? We’re in!

More Clarity for Who and How Often on Mammograms

Mon, 07 May 2012 13:37:49 -0500

Since 2009, when the U.S. Preventive Services Task Force threw a grenade into the “mammograms for everyone” approach to women’s care, researchers, doctors and women have been wondering just who should get a mammogram, when and how frequently.

As widely reported last week, the results of new studies are helping to tease out the variables in this equation. Thanks to a greater appreciation that more tests don’t necessarily render better care, and that such overuse can cause patient harm, people are learning that customized medicine is superior medicine.

As the Los Angeles Times noted, “Of the various recommendations put forth by the U.S. Preventive Services Task Force in 2009, none generated more ire than the suggestion that annual mammograms could do more harm than good for most fortysomething women, who are far less likely than older women to get breast cancer….

“The new research was designed to identify women who could benefit the most from having mammograms early and often.”

The task force, an independent panel of health experts which advises the federal government, suggested more than two years ago that women older than 50 should have a mammogram every two years instead of annually, and that most women in their 40s should bypass the test altogether. Until then, women over 40 routinely were advised to have a mammogram annually.

The new research found that among women 50 to 74, for every breast cancer death averted by screening, 146 women received a false-positive reading -- a false alarm -- on a mammogram. And for every year of life someone gained thanks to a mammogram’s early detection of breast cancer, 8.3 false positives led to unnecessary biopsies, weeks of worry and sometimes surgical complications.

Two markers stood out for researchers as indicators that a 40-year-old should have regular and more frequent mammograms: a woman whose mother or sister was diagnosed with breast cancer, and women with unusually dense breast tissue.

These people, the studies concluded, carry at least twice the average risk of developing breast cancer in their 40s. For such women, according to the study in the Annals of Internal Medicine, routine screening outweighs the risk of false alarms and unnecessary, often invasive and uncomfortable tests.

One of the studies combined and analyzed data from 61 previously published studies. The other employed computer models to predict the health outcomes of approximately 44,000 simulated women who had their first mammogram at 50. The simulation was revised to show their outcomes had they begun screenings at 40. Then it compared the rates of false alarms, breast cancer diagnoses and mortality in both groups.

For the younger group, researchers found that the only ones who stood to benefit to a similar degree were those whose breast cancer risk was roughly double the norm for their age group. Having a first-degree relative — a mother or sister — with a breast cancer diagnosis more than doubles a 40-year-old's own risk of developing the disease. Two or more first-degree relatives with breast cancer bump up the risk nearly fourfold.

Increased risk also was seen in women whose breasts are composed of significantly more glandular than fat tissue. That also doubled the risk of breast cancer risk for someone in her 40s.

The confounding element here is that dense breasts make mammograms harder to read: Cancerous tumors aren’t as apparent within glandular tissue as they are within fat. Radiologists, who review mammograms, and doctors lack established standards to define and grade breast density.

Other risk factors identified in the new studies were:

biopsies--women whose breast biopsies were benign have an 80 percent greater risk of getting cancer in their 40s;

oral contraceptives—30 percent greater risk;

never having given birth—25 percent;

first child after 30—20 percent increased risk.

As we’ve discussed before, percentages of increased risk don’t necessarily convey an accurate picture. The commonly heard refrain that a woman’s risk of breast cancer is 1 in 8 is misleading. That’s a skewed metric that fails to consider not the risk at age 40, but the lifetime risk for a woman who lives to age 90. The real figure for young adults is more like 1 in 813.

The new studies, of course, help women understand if their risk is higher or lower than average.

As the whys and wherefores of mammograms evolve, women and their doctors should focus on two things: getting an accurate family history, and understanding their individual breast anatomy. The state of the art today makes those the drivers of when to begin and how often to get a mammogram.

The Ugly Underbelly of the Blockbuster Drug Pradaxa

Sun, 06 May 2012 13:29:07 -0500

If you think the word “blockbuster” is reserved for popular entertainment like “Game of Thrones,” you probably don’t need to take a blood thinner. Such drugs are prescribed to people at risk of stroke from conditions such as atrial fibrillation (irregular, rapid heart rate).

In Pharma Land, the drug Pradaxa is considered a blockbuster, or a drug whose annual sales top $1 billion. It’s touted as superior to other anticoagulant drugs because it requires less monitoring.

But just as a blockbuster movie can be ravaged by critics, a blockbuster drug can collect seriously bad reviews.

Since its U.S. introduction in 2010 by Boehringer Ingelheim as an alternative to Coumadin (warfarin), Pradaxa has engendered hundreds of adverse event reports to the FDA, according to AboutLawsuits.com, concerning hemorrhages and internal bleeding. Lawsuits charging wrongful death have cited Institute for Safe Medication Practices (ISMP) records tallying scores of deaths from bleeding.

Other anticoagulants, such as Coumadin, also pose a risk of bleeding, but patients on warfarin can be given vitamin K as a fast-acting reversal agent to bleeding problems. Pradaxa lacks such an antidote to disaster.

Lawsuits also challenge the rigor with which Boehringer Ingelheim researched its drug and allege that the company promoted it as an alternative to the older, safer warfarin despite failing to warn about the lack of a reversal agent.

More incidents of uncontrollable bleeding with Pradaxa, according to the ISMP, were reported during the first quarter of 2011 than were reported for any other drug monitored by the institute. More than 500 reports were made about Pradaxa versus 176 for warfarin, which ranked second.

Researchers have suggested that Pradaxa drug trials were flawed, and the FDA is investigating the bleeding claims, as are agencies in Europe and Canada.

But if you’re Boehringer Ingleheim you don’t dare argue with success. The company recently boasted that the launch of Pradaxa was “among the most successful market introductions in the pharmaceutical industry in the past few years.”

Not if you’re a Pradaxa patient bleeding to death with no way to stop it.

Although the FDA still considers Pradaxa a worthy drug, it has recommended that Pradaxa patients immediately contact their doctor if they detect signs of bleeding problems. They are:

unusual bleeding from the gums;

frequent nose bleeds;

unusually heavy menstrual or vaginal bleeding;

severe, uncontrolled bleeding;

pink or brown urine;

red or black stool that looks like tar;

unexplained bruises that grow over time;

coughing up blood or blood clots; and/or

vomiting blood or a substance that looks like coffee grounds.

I’m Sick! I Read It on the Web!

Wed, 02 May 2012 18:50:23 -0500

A little knowledge is a dangerous thing.

So said the 18th century’s Alexander Pope in “An Essay on Criticism.” So said, in so many words, the 19th century’s T.H. Huxley in “On Elementary Instruction Physiology.” So said the 20th century’s Albert Einstein, who added a second sentence, “So is a lot.”

Each of these people turned up in a Google search as the author of that expression. If you Googled “dangerous knowledge” in the hope of finding out who who said it first, chances are excellent you would get a misguided result. You can find knowledge on the ‘net, but finding context and fact is a bit more daunting.

According to a Pew Research Center study, more than 6 in 10 adults search for health information online. Nearly 6 in 10:

read someone else's commentary or experience about health or medical issues online;

consulted rankings or reviews online of doctors or other providers;

consulted rankings or reviews online of hospitals or other medical facilities;

signed up online to receive updates about health or medical issues;

listened to a podcast about health or medical issues.

Certain topics showed large gains in adult consumer interest over a seven-year period:

a specific disease or medical problem (49 percent, up from 36 percent);

a medical treatment or procedure (41 percent, up from 27 percent);

prescription or over-the-counter drugs (33 percent, up from 19 percent);

alternative treatments or medicines (26 percent, up from 16 percent);

depression, anxiety, stress or mental health issues (21 percent, up from 12 percent);

experimental treatments or medicines (15 percent, up from 10 percent).

We’re big fans of medical consumers informing themselves about health topics and quality of care. But context and and factual information aren’t always found where Googlers are looking.

A recent study published in Psychological Science shed some light on the common consumer habit of matching one’s symptoms with disorders described on the Internet to make wholly misguided self-diagnoses. Got a headache, nausea and fatigue? Websites listing these symptoms prompt far too many people to conclude erroneously that they have brain cancer.

As explained in a story on The Daily Beast, the response is a Web-enabled hypochondria called “cyberchondria,” and it can be as complicating as it is helpful.

The Psychological Science researchers said the brains of cyberchondriacs are like those of gamblers. It’s about pattern recognition, and what can go wrong when the brain tries to impose order on chaos. Cyberchondriacs who see patterns in lists of symptoms make the same mistake as gamblers who see patterns in random events such as consecutive rolls of the dice. The latter might conclude, erroneously, that a positive result on one or two rolls will repeat. The former might conclude that experiencing some symptoms in a list of several means they must have all of the other symptoms as well.

The researchers made up a type of thyroid cancer for which they also made up six symptoms. They composed three differently ordered lists of the same six symptoms. One grouped the milder, more common symptoms (fatigue, shortness of breath) at the top, and the more severe and rarer symptoms (pain in the throat or neck, lump in the throat or neck) at the bottom. One list ordered the more severe symptoms first, followed by the milder ones. The third mixed all the symptoms.

Different groups of healthy subjects were shown one of the lists, told to check off their symptoms, then asked how likely they were to have that cancer relative to the average American. Both groups with the lists of mild symptoms separated from severe symptoms were far more likely to believe themselves at risk for this fake problem than the group with the randomly listed symptoms.

The gift of pattern recognition can undermine the basic logic of probability. Gamblers say they have a “hot hand”; cyberchondriacs believe they have “hot symptoms”—if they hit the first two in a list, they believe they must have the third one as well.

There’s nothing wrong with a little knowledge, but if you get it from the Internet, you must ensure your source is credible. Check out our newsletter, “Essential Tips for Doing Your Own Health-Care Research.” Other solid sources for medical information include scientific journal abstracts, university research summaries and articles from established centers of medical practice such as the Mayo Clinic and reports by government organizations such as the Centers for Disease Control and Prevention and the National Institutes of Health.

Knock yourself out with medical research, but refrain from self-diagnosing until you consult with a medical professional. You might have a brain tumor, but it’s far more likely that your eyeglass prescription has changed, your milk has gone a bit sour and you’re not getting enough sleep.

As Pope said:
“A little learning is a dang’rous thing;/Drink deep, or taste not the Pierian spring:/There shallow draughts intoxicate the brain,/And drinking largely sobers us again.”

Re-Thinking Diabetes Care

Mon, 30 Apr 2012 18:36:03 -0500

People diagnosed with diabetes quickly learn to test their own blood sugar levels several times a day using a home glucose kit. They also know that their periodic visits to a laboratory for tests measuring their A1C level should show a value no higher than 7, which is a widely accepted benchmark that the disorder is being well managed.

At least it used to.

These days, diabetes is among the disorders many enlightened practitioners are including in “patient-centered” care. That trendy term signifies the evolution of the practice of medicine that, along with a clinical diagnosis, embraces the individual’s circumstances and values to treat a disorder, and puts a priority on the sharing of medical decisions. That’s opposed to the traditional default of treatment based on technology, doctor preference/convenience, hospital equipment/protocol/location and the pure science of eradicating or ameliorating disease.

As explained in a story on NPR.org, “new diabetes management guidelines .. will cut many people with diabetes some slack.” The American Diabetes Association (ADA) officially now encourages diabetics and their doctors to determine an A1C level appropriate for each patient.

People who are diagnosed with Type 2 diabetes at a younger age reasonably might aim for a level of 7 or 6; older folks with accompanying heart disease might manage the disorder sufficiently if their level is 8, according to a study published in Diabetes Care.

"It it unrealistic to expect that everybody with diabetes should have the same goals and use the same medication," Vivian Fonseca, president of the ADA, told NPR.

As the director of one hospital diabetes center said, "It was a misguided public health concept that one number would make it easy for patients and doctors to remove the ambiguity and prevent diabetes complications. The problem is getting to goal safety and with patients' buy-in."

We’ve discussed the need for patients and doctors to craft a diabetes management program that acknowledges individual situations. But the new guidelines and the focus on customized care also shines a clarifying light on the knee-jerk use of diabetes drugs.

In a companion story on NPR.org, the American College of Physicians (ACP) encourages newly diagnosed diabetics and their doctors not to fall for the “newest is best” approach toward pharmaceuticals. This reflects the groundswell of support for rejecting unnecessary and expensive tests and treatments that often worsen a patient’s condition.

The ACP, NPR reports, advises some patients against taking certain drugs, and even directing them toward treatment from nonphysician competitors. There are lots of ways to manage diabetes, and taking drugs is only one. The patient-centered approach is part of what the organization calls “high value care.” Instead of taking vigorously marketed diabetes drugs such as Actos, Januvia and Avandia, Type 2 diabetics should opt first for an older generic drug.

We’ve covered the adverse events associated with these brand-name drugs here, here and here.

The ACP recommends that the first choice for newly diagnosed diabetics should be metformin, a generic drug nearly 20 years old. A month’s supply of metformin costs about $14; a month’s supply of Actos runs $230-$370, and the cost for Januvia is about $265. According to ACP guidelines, metformin "lowers blood sugar levels more than newer drugs do.” It also reduces bad cholesterol; the newer drugs don’t, and sometimes they raise it.

Steve Weinberger, CEO of the ACP, told NPR that, "In these days of crisis in health care costs, the medical profession should take its ethical and professional responsibility to do what we can to reduce costs while not compromising care." He realizes that doing so requires fortitude, thanks to the financial incentives physicians often have to prescribe more expensive treatments. Hospitals also tend to supplant the simpler and less expensive with the newer and more remunerative care option.

If your doctor isn’t heading up a patient-centered diabetes team, maybe it’s time to find a new coach.

Risk of Lethal Blood Clots Increases in Same-Day Surgery

Sun, 29 Apr 2012 18:12:19 -0500

Outpatient surgery is an increasingly popular medical option, thanks to the cost of inpatient care and the expanding capability of outpatient facilities. More than 6 in 10 surgical procedures are conducted on a same-day-to-home basis. They include operations for cancer, orthopedic and gastrointestinal problems and plastic surgery.

But as we recently wrote in a related post, ambulatory care centers lack the rigorous oversight that is standard protocol for hospitals.

Now, a new study published in The Annals of Surgery raises the flag of concern that outpatient procedures carry a higher risk of life-threatening blood clots than similar inpatient care. Hospital patients undergoing surgery generally are apprised of the possibility of venous thromboembolism (VTE), and how to thwart it. VTE is a blood clot that forms within a vein, usually in the calf in an immobile leg. It's potentially lethal because it can migrate to the lungs (pulmonary embolism, or PE) and impede the ability to breathe, sometimes fatally.

Unlike inpatients, people who under go outpatient surgery often are not warned to watch for signs of VTE, according to the study’s authors. Less than half of outpatient centers have VTE prevention guidelines. Worse, the study showed, even fewer adhere to them.

Approximately 300, 000 Americans die each year from PE each year, most because of a failure of diagnosis rather than unsuccessful treatment. Surgical patients and their caregivers must be aware of VTE symptoms in order to neutralize the threat.

Researchers analyzed a national registry of more than 200,000 outpatient surgeries across the country to design a paradigm to predict a patient’s risk for VTE. Their study showed that 1 in 84 patients at highest risk suffered a dangerous blood clot after surgery. It’s well-known that vein surgery and arthroscopic surgery boost the risk for VTE. Other risk factors include:

advanced age;

obesity;

longer surgery;

pregnancy;

active cancer.

The more of these factors a patient presents, the greater the risk.

“[The] data are in stark contrast to provider and patient expectations that outpatient surgery is a low-risk event,” said Christopher J. Pannucci, a surgeon at the University of Michigan and the the study’s lead author. “It also underscores the importance of evaluating a patient’s individual risk factors as opposed to procedure-type alone.”

The study signaled the need for better screening and prevention of venous thromboembolism especially for people who are obese and/or older than 65. Researchers advised that the informed consent process for outpatient surgery provide clear information about the risk for developing VTE, just as such guidelines are routine for inpatient surgery.

If you are scheduled to undergo same-day surgery, ask for the facility’s patient guidelines for preventing blood clots. If it has none, consider getting treatment elsewhere, or at least consult with your doctor about how to prevent VTE. No one is immune from this potentially lethal but quite preventable condition.

Medical malpractice is a huge problem in blood clot management, as this article on our firm's website discusses. You can read patient safety tips on blood clot prevention in another article here, which talks about the key warning signs of blood clots in the legs, and different warning signs of clots that may have moved to the lungs.

Legislation Aims to Bring Fairness to Patients Hurt by Generic Drugs

Wed, 25 Apr 2012 21:48:29 -0500

Last year, a U.S. Supreme Court ruling prohibited injured patients from suing generic drug companies. Because such companies lacked control over the content of their labels, the court said, if they’re unable to print warnings about drug side effects, patients shouldn’t be able to sue them.

A previous Supreme Court decision allowed patients who took brand-name drugs to sue their manufacturers. Since the decision last year, cases have been thrown out in which patients claimed harm from taking generic drugs. But in many of those cases, the plaintiffs suffered the same injuries as people who took the brand-name versions.

Last week, companion bills were introduced in both houses of Congress to address the inconsistency.

“If a consumer takes the brand-name version of drug, she can sue the manufacturer for inadequate warnings,” said Sen. Patrick Leahy, D-VT, in a statement. “If the pharmacy happens to give her the generic version, she will not be able to seek compensation for her injuries,” he said.

The legislation, as reported by The New York Times, would permit generic drug companies to update warning information about the drugs they manufacture. That would enable patients to sue them if they failed to warn about the risks associated with their drugs.

If it seems like a no-brainer that what’s good for the goose is good for the gander, the outlook for passage isn’t exactly rosy: The Republican-controlled House is likely to vote thumbs-down.

Consumer groups have requested that the FDA take similar action, but the agency has demurred.

As The Times reported, generic drug companies have opposed the label content measure on the grounds that it could create chaos. What if several different drug companies publish conflicting warning information about the same drugs? Now, only brand-name drug companies may update the labels, including everything about a drug’s uses, dosages and risks. Then, generic manufacturers must follow suit.

You’d expect Big Pharma to wiggle away from accountability. Let’s hope Congress does the right thing.

"Say What? The Problem with Hearing Aid Costs?"

Tue, 24 Apr 2012 04:25:28 -0500

The next time you’re annoyed by someone with impaired hearing who constantly asks you to repeat what you’ve said, try to restrain the urge to ask,“Why don’t you get a hearing aid?”

Because for many such folks, the answer might be that they can’t afford it. As reported by KaiserHealthNews.org (KHN), a hearing aid typically costs a few thousand dollars, sometimes more, and most insurance plans don’t cover the cost. Even Medicare, whose older patient demographic is prime for hearing loss, generally keeps the purse strings closed.

Only 1 in 4 of the 35 million adults in the U.S. who would benefit from having a hearing aid actually gets one, according to KHN.

As disappointing as it is to know that hearing loss isn’t considered worthy of coverage, the situation isn’t as bad as it used to be. A survey of people who bought hearing aids in 2008 showed that nearly 4 in 10 received an insurance contribution, which was somewhat more generous than four years earlier.

Insurance plans usually cover tests (or some of them) to evaluate hearing. But if the loss is sufficient for the care provider to prescribe a hearing aid, insurance generally amounts to only $500 to $1,000 for the device once every two to five years. They need to be replaced, on average, every four to six years.

One woman whose story was told in the KHN report began to lose her hearing as a young woman. She got her first hearing aid at 35, and by the time she was 40 had one in each ear. She estimates that she bought 11 hearing aids over the following two decades that cost approximately $25,000, all of which she paid as a customer of the individual health insurance market.

Still, there is cause for hope. A program introduced this year by UnitedHealthcare called hi Health Innovations is intended to make affordable hearing aids—ranging in cost from $749 to $949—available to both its members and the general public. The discounts of 30 to 50 percent are available because the company buys in bulk. Plan members might get an even better deal.

Patients can take a hearing test online, submit it for evaluation and choose among the four HI hearing aids. The selection is programmed to the patients’ specifications and mailed to them. The online operation also offers help with service issues, and there’s a toll-free customer service line at (855) 523-9355.

HI audiologists and hearing aid dispensers (who are also licensed, but with less training than audiologists) are located in major cities around the country. Email the company for information at hicustomerservice@hihealthinnovations.com

The program is too new to assess success, but advocacy groups are hopeful it can address the gaping hole in treatment for hearing loss. As Lise Hamlin of the Hearing Loss Association of America said, "We think getting hearing aids into people's hands is hugely important. But the test may be wrong or the hearing aids may not work for most people. So we're taking a wait-and-see attitude."

Some hearing loss is so profound a hearing aid is not the solution. Surgery might be. In that case, insurance coverage, including Medicare, generally is available. The procedure involves a small electronic device called a cochlear implant that stimulates the auditory nerve.

For more information about hearing loss and how to treat it, visit the Hearing Loss Association of America website.

More Evidence that Throwing Bucks at Cancer May Not Improve Survival

Mon, 23 Apr 2012 05:33:17 -0500

A recent study published in Health Affairs either proves the superiority of U.S. medical care for cancer, or illustrates again how ignorance of basic statistical principles can lead to wrong conclusions.

The study found that U.S. cancer patients who were diagnosed between 1995 and 1999 lived, on average, 11.1 years after their diagnosis. Similar patients from 10 European countries lived an average 9.3 years. By 1999 (the last year the researchers analyzed), the average U.S. expenditure per cancer case was $70,000. That was nearly 50 percent higher than the cost in 1983. The cost in Europe was $44,000—16 percent higher for the same interval. Using standard figures for each extra year of life, the researchers concluded that the value of the U.S. survival gains outweighed the cost by an average $61,000 per case. They pronounced the additional spending on cancer care in the United States "worth it."

But a Reuters story analyzing the research begged to differ. "This study is pure folly," Dr. Don Berry, a biostatistician at MD Anderson Cancer Center in Houston, told Reuters. "It's completely misguided and it's dangerous. Not only are the authors' analyses flawed but their conclusions are also wrong."

Reuters also found the credentials of the study’s lead author, Tomas Philipson of the University of Chicago, wanting. He’s a health economist who served in the administration of President George W. Bush and advised the McCain presidential campaign on health-care issues. The point? The research might not be as unbiased as science demands.

Thirteen common cancers were examined in the study. Researchers analyzed survival—how long a patient lived after being diagnosed—in the period from 1983-1999. They looked at survival gains, or how long patients diagnosed in later years lived compared with those diagnosed earlier in the period. Those gains, they said, demonstrate the progress countries made in treating cancer.

Sounds reasonable. But survival data are tricky; they’re not cold, irrefutable numbers that can quantify success, thanks to something called lead-time bias.

Take two hypothetical people who both get the same kind of cancer on the same day. One of them gets an immediate diagnosis and lives another two years. The other is diagnosed eighteen months after the first, and lives only six months. Patient No. 1 had a "better" survival rate -- two years compared to the six months of Patient No. 2, but she didn't live any longer. She just knew she was sick earlier. Both patients lived two years. That's "lead-time bias" at work.

That’s why, as the Reuters analysis says, “Crediting medical care with ‘improving survival’ is therefore misleading, cancer experts have long argued. Lead-time bias makes it seem patients live longer, but the only thing that is longer is the number of years they know they have cancer…”

But Philipson’s team based its conclusions on survival data, arguing that because U.S. cancer mortality rates declined faster than those of Europe, they’re evidence of survival gains.

Berry articulated a related point with which readers of this blog will be familiar: that overdiagnosis is a problem. Cancer screening, particularly for breast and prostate cancers, is more common in the U.S. than in Europe, and the more testing, the more cancer will be found. But as Berry noted for Reuters, "These are cancers that tend to be slowly growing and many would never kill anyone."

Link here and here to read our posts about the misguided use of screenings for breast and prostate cancers, respectively.

If, in a diagnostic procedure, you find what you’re looking for, does that denote a successful test? Not if it makes a healthy person a cancer patient if the tumor otherwise is not life-threatening. Including such cases, whose numbers are higher in the U.S. than in Europe, makes survival data bogus.

The Health Affairs study showed survival gains in the U.S. versus Europe were greatest for prostate cancer; breast cancer claimed the second-best U.S. survival data--the two cancers where lead-time bias figures most prominently in overdiagnosis.

It’s interesting that Europe had the survival edge in data for melanoma and colorectal and uterine cancer survival gains.

According to Reuters, U.S. cancer mortality places the U.S. in the middle of countries reporting to the Organization for Economic Co-operation and Development.

If that’s not enough to prompt questions about the “Spend More! Live Longer!” theory of cancer survival, consider this: Even the study’s researchers concede that it’s impossible to state that improved survival is a direct result of spending money on cancer care. It might result from improved screenings that detect the “pseudo-disease,” or nonaggressive, nonthreatening tumors that artificially enhance survival data.

And Philpson said, “In the last decade, spending in the U.S. has increased more than in Europe. I would be extremely surprised if the survival gains haven't continued. But it is a much more open question whether that additional spending has been accompanied by an increase in longevity."

According to Reuters, in 2004 (the last year for which figures were available), the U.S. spent $72 billion on cancer care. It also noted that Philipson’s research was supported in part by Bristol-Myers Squibb Co. That company makes a melanoma drug, Yervoy, that costs $120,000 for a full course of treatment.

Certainly the cost of cancer drugs have increased. Dendreon Corp. makes Provenge for prostate cancer at $93,000 per treatment. Bristol and Eli Lilly and Co. make Erbitux at $100,000 per year. The researchers said their analysis "does not imply that all treatments are cost-effective."

Remember, Philipson is an economist. His scholarship concerns how much an additional year of life is worth. His researchers assumed the value to be $150,000 to $360,000.

No wonder economics is referred to as “the dismal science.”

Footnote: Here is a good explanation from "the Incidental Economist" blog of the "lead-time bias" problem in medical statistics and why the correct number to focus on is death rates, not survival rates. However, important caveat from the same blog: Survival rates are very important to any individual patient, because they can tell you how long YOU might live with a particular cancer at a particular stage. The importance of death rates is on the macro level: Does early screening bend the death curve down, or not?

Lung Cancer Screening Could Put Millions of Patients on the Medical Assembly Line

Sun, 22 Apr 2012 21:17:17 -0500

A couple of weeks ago, a study published in Health Affairs reinvigorated the conversation about the usefulness of screenings for lung cancer. We have been among the voices questioning the widespread use of certain screenings because, in many cases, they are inappropriate, unnecessarily expensive and possibly harmful.

Now, another voice of reasoned consideration and moderation has reinforced the growing belief that for too long many diagnostic tests have been conducted not because they signify the best in medical care, but almost by habit bolstered by studies that seem significant but, on closer inspection, don't measure up.

Writing on HealthNewsReview.org, Harold DeMonaco, director of the Innovation Support Center at the Massachusetts General Hospital, said that the study authors provided some interesting numbers to back up their conclusion that insurers should screen high-risk individuals (long-term smokers who are at least 50) with low-dose spiral CT scans. That technology creates multiple images of the entire chest via X-rays, whereas a standard chest X-ray is a single snapshot of the entire chest.

“Of the 18 million or so smokers who fall into their eligibility criteria,” DeMonaco wrote, “they showed a potential for … 130,000 additional survivors of lung cancer due to early detection. It’s hard to argue that saving this many lives is not important. But the study does not look into the negative aspects of the double-edged sword that is lung cancer screening. While we are constantly berated for being anti-screening, it is important for people to understand what the risks and benefits are for any medical procedure including screenings.”

He referred to a large study funded by the National Cancer Institute (NCI) to determine whether screening with low-dose CT, as compared with chest radiography, would reduce mortality from lung cancer among high-risk smokers. We reported on that as well.

The NCI study, DeMonaco said, was sufficiently similar to the one reported by Health Affairs for its data to be relevant now. About 1 in 4 people who got spiral CT scans tested positive. If extrapolated per the current study, the numbers add up to 4.32 million positive findings. But more than 9 in 10 of those proved to be false positives. (See our post about the perils of false positives and false diagnoses.)

In revisiting this unwelcome scenario in this application, DeMonaco explained “that 4,086,720 people screened would have a false positive result. All would likely suffer from some degree of angst. Of those with false positive findings, 0.06 percent had a major complication possibly related to subsequent invasive procedures in the NCI sponsored study.”

So 108,000 people would experience a serious adverse event resulting from a procedure they had because the original scan showed falsely positive. Said DeMonaco: “Those events need to be considered when thinking about the 130,000 potential lives saved through screening. Few medical procedures are without risk and each should be viewed as a double-edged sword. Benefits as well as risks need to be considered. Reporting on just the benefits provides readers with only half the story.”

If your doctor prescribes a screening test, ask:

What are the possible benefits?

What are the possible harms?

How often do harms occur?

Are there alternative tests?

If you’re not satisfied with the answers, or if you don’t believe your concerns are be given fair consideration, seek a second opinion.