March 26, 2015

Suggested Reading: Hyping Hypothyroidism?

Twelve in 100 Americans will be diagnosed at some point in their lifetimes with a thyroid disorder. Hypothyroidism, or under-active thyroid gland, is treated with the drug levothyroxine, which has been called the second-most frequently prescribed drug in the U.S.

As a long and interesting article in discussed, one of the hottest controversies in endocrinology is hypothyroidism and its treatment. Thyroid disorders are off-the-charts more common in women than men, and possibly as many as 2 million people, according to some estimates, have a thyroid disorder that hasn’t been diagnosed.

“Some might lack access to or money for doctors,” according to the story, “but for many, it’s just that the symptoms of hypothyroidism are so vague. Who doesn't feel tired, fat and depressed sometimes?"

“‘The symptoms of hypothyroidism are diverse and they mimic the symptoms of everyday life,’ said Scott Isaacs, the medical director at the Atlanta Endocrine Associates in Georgia. ‘They could be the thyroid, but they could be something else.’"

Read the whole story here:

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March 24, 2015

Huckabee the Huckster: Promoting Bogus Diabetes Treatment for Political Gain

If you think the reputation of politicians couldn’t possibly sink lower, at least one potential presidential candidate proves you wrong. Mike Huckabee, former governor of Arkansas and a 2008 Republican presidential candidate, starred in an Internet commercial for an “alternative” treatment for diabetes.

Or, as the New York Times described it, a “dubious” treatment. Even that is being kind.

From a wood-paneled study, the folksy Huckabee implores viewers to ignore “Big Pharma,” and treat their type 2 diabetes with a “weird spice, kitchen-cabinet cure” of dietary supplements.

“Let me tell you, diabetes can be reversed,” Huckabee says. “I should know because I did it. Today you can, too.”

The American Diabetes Association, as you might expect, is not among Huckabee’s medical campaign supporters.

His motivation for giving medical advice, according to The Times, is because on his first try at the White House, he ran out of money. So the Internet pitch is one of the “highly unconventional income streams” he has pursued. In addition to endorsing the diabetes “treatment," he has sold ads on email commentaries distributed to his supporters.

A spokeswoman for Huckabee told The Times that he had ceased to be a spokesman for the diabetes cure a couple of weeks ago, possibly because such endorsements made him look less than presidential.

That seems to us the lesser of two evils — isn’t it more important to avoid promoting not only bogus but possibly harmful medical advice when you’re wholly unqualified to do so?

At least former presidential candidate and U.S. Sen. Bob Dole was paid to advertise a legitimate drug (Viagra), never mind the damage that campaign might have done to his statesmanlike image.

Huckabee has been applying snake oil for some time, as The Times reported. An ad accompanying one of his emails in January claimed that a miracle cure for cancer was hidden in the Bible. The ad linked to a video offering a booklet about the “Matthew 4 Protocol,” which was free … if you bought a $72 subscription to a health newsletter.

As The Times story said, “Although a disclaimer on the emails says Mr. Huckabee does not endorse these products, that might not be enough to dissociate him, as a future presidential aspirant, from their claims, which are designed to pry open the wallets of small-donor conservatives, some of whom distrust mainstream sources of information.”

At least one fellow conservative, Erick Erickson, founder of the blog Red State, has criticized ads for products and outside political groups that he calls “hucksters.”

The “Diabetes Solution Kit” Huckabee’s hawking is a $19.95 booklet with advice on eating, exercise and dietary supplements. He promises the information will disclose “all the natural secrets that are backed by real science that really work.”

Uh, huh, and if you believe that, you might want to invest in oceanfront real estate in Arizona.

One video isn’t science, it’s science fiction, and peddles a diabetes “cure” consisting of cinnamon and chromium picolinate, a chemical compound sold as a nutritional supplement.

The American Diabetes Association says such dietary and herbal supplements are about as effective for treating diabetes as bourbon is for treating dehydration. And we’re paraphrasing here…

“Most big pharma companies don’t know squat about how to reverse your diabetes,” the video says, and Huckabee, who lost more than 100 pounds after being diagnosed with type 2 diabetes in 2003, states, “Techniques just like you’re going to find in this kit worked for me.”

But earlier this month at a political appearance in Iowa, he was asked if he had used cinnamon and chromium picolinate to reverse his diabetes, and Huckabee said, “No, I reversed it by taking better care of my health.”

“Pressed about the dietary supplements promoted by the company he endorses,” according to The Times, “for which he was paid an undisclosed fee, he said: ‘I’ll do anything that promotes good health. Yes, sir.’ ”

Maybe he meant, “I’ll do anything to make money for my political coffers, even if it encourages people to ignore proven medical treatment and risk their health chasing dreams.”

Even though Huckabee supposedly ceased promoting the Diabetes Solution Kit earlier this month, its producer, Barton Publishing of Brandon, S.D., still included his endorsement on its website.

Customers of Barton Publishing have posted objections online to the company making exorbitant and unauthorized charges to their credit cards. A Times reporter ordered the booklet Huckabee promoted for $19.97 for a downloadable copy and $19.95, plus shipping, for a printed copy, and found a $120.08 charge to his Visa card, which included a $67 coaching video that was not ordered.

A slimy business making slimy product claims.

“Although supplements line the shelves of pharmacies and supermarkets,” The Times explained, “scientific organizations say the evidence for their help in treating diabetes, the seventh leading cause of death in the United States, comes up short.”

According to the American Diabetes Association, “Research has not been able to prove that dietary or herbal supplements (including omega-3 supplements, cinnamon and other herbs) help to manage diabetes.”

Read the cautionary information about herbs, supplements and alternative treatments provided from the American Diabetes Association here. And see Patrick’s newsletter about nontraditional medicine.

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March 23, 2015

Disagreement Between Fed Agencies Thwarts Medical Device Safety

Eight years ago, Congress passed legislation to include identification numbers on individual medical devices so that if one caused a problem, its origin could be determined and whether the malfunction was rare or of a broader concern of which the public should be aware. The program still isn’t operational.

As reported in the Wall Street Journal, (WSJ) the FDA had intended to use billing claim data bearing the “unique device identifier” (UDI) by 2012 to monitor the safety of devices such as implanted heart defibrillators and artificial joints. Not until last year did manufacturers start embedding the numbers on their products. (The UDI is different from model numbers and serial numbers, which have been on medical devices for a long time.)

But in what the WSJ calls a “behind-the-scenes bureaucratic conflict,” The Centers for Medicare & Medicaid Services (Medicare, or CMS) steadfastly has opposed the FDA’s plan to monitor safety via claims data and UDIs. CMS, the paper reported, contends that including the UDI on the medical claim forms it receives from hospitals is technically difficult and too expensive.

In February, former Medicare Administrator Marilyn Tavenner voiced support for some other way than claims reporting for collecting UDIs, and although she has left the agency, the WSJ said other Medicare officials toe the same line.

That’s in opposition to Sylvia Mathews Burwell, the secretary of Health and Human Services (HHS), which oversees CMS and the FDA. During her Senate confirmation last year, Burwell indicated that the Sentinel Initiative — the FDA’s national electronic system to track the safety of drugs, biologics and medical devices once they reach the market — would benefit by incorporating UDIs into its claims data sources.

Mark McClellan, a former Medicare administrator, told the WSJ that “what you’re hearing now is CMS channeling the concerns of hospitals” that billing changes could be expensive for them, too.

So are patient safety and transparency once again taking a back seat to special interest pressure?

As readers of this blog know, deficient medical devices are huge contributors to adverse medical outcomes. For example, endoscopes; one type is responsible for the recent outbreak of the superbug CRE (carbapenem-resistant Enterobacteriaceae) that has killed some people and harmed others undergoing diagnoses for gastroenterological problems.

Other common devices with notable records of failure in recent years include defibrillator wires, and metal hip joints. As the WSJ noted, such devices have “killed or injured thousands of people before the FDA — or the companies themselves — realized the scale of the malfunctions.”

Medicare has opposed committees of experts who have worked on how the UDI might appear in billing data. One such panel, the Accredited Standards Committee X12, sets the details of electronic medical bills.

A cardiologist who has served on it and another UDI-related committee told the WSJ that Medicare and insurers could do well financially from the UDI by identifying unsafe devices before they became widespread.

An executive with insurer Aetna told the paper that it’s “critically important” for Medicare to proceed with the program, partly because private insurers generally follow Medicare’s lead in formatting their bills, and that the UDI system not only would improve quality and lower cost, but that its data, with the model and the brand, would provide the ability to do comparative studies with other devices.

“Yet in recent emails within the X12 standards committee,” the paper reported, “Medicare staffers wrote that Medicare ‘does not support any scenario wherein the UDI is integrated into a claim transaction, stored in claims history, or utilized anywhere in the claims adjudication and payment process.’”

Tavenner had suggested that including device-specific numbers into electronic medical records or device registries kept by companies could be enough to promote safety, but what if a patient gets a heart device in one state, then travels to another and has a fatal complication of it? UDI supporters say insurance databases are the best way to capture these data.

Three years ago, the FDA’s medical-device chief scientist told the WSJ that “the unique identifier is the real game-changer” when it’s part of an insurance claim. FDA officials declined to be interviewed for the paper’s recent article, but said the device identifier “can provide important benefits.”

Other consumer and medical interest groups are joining the call for UDI, including AARP, Pew Charitable Trusts, the American College of Cardiology and the Leapfrog Group.

It’s time for the competing agencies within the federal government to get it together, and adopt a plan that Congress intended and that patients deserve.

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March 22, 2015

The Paleo Diet: Should You Eat Like a Caveman?

You’ve probably heard of the paleo diet — it’s the latest food trend that promises to improve health, aid in weight loss and make life more wonderful in every way.

Is there anything more subject to fashion than diets?

A recent analysis of the paleo diet in the Washington Post helped readers understand the popularity of eating like a caveman. Promoters of the paleo diet, it said, find fault with modern diets because they rely too much on processed food.

The Paleolithic Era extended from about 2.6 million to 12,000 years ago — or from the earliest known use of stone tools through most of human technological prehistory. Our Paleolithic forebears ate what we might call raw materials — meat from grass-fed animals, fish, fruit, vegetables, eggs, tree nuts. The paleo diet forbids grains, cereals, legumes (such as beans and peanuts), potatoes, salt, dairy products, processed foods and refined sugars — anything people ate after the advent of agriculture.

The Post interviewed author Loren Cordain, who wrote “The Paleo Diet: Lose Weight and Get Healthy by Eating the Foods You Were Designed to Eat.” The human body, it says, does best with the nutrition available before people started farming and raising livestock.

Cordain, a Ph.D. who taught in the Department of Health and Exercise Science at Colorado State University, believes that we should eat like our paleo ancestors because our genes haven’t changed that much in the 300 or so generations since they flourished. We’re supposed to hunt, fish and gather from the natural environment because our bodies haven’t evolved to run on the fuel found in grocery stores.

As you might imagine, other experts disagree. The Post talked to Daniel Lieberman, professor of human evolutionary biology at Harvard University and author of “The Story of the Human Body: Evolution, Health, and Disease.” He said that evolutionary adaptations don’t reflect health as much as they do reproductive fitness: “Natural selection really only cares about one thing, and that’s reproductive success.”

If the paleo people were healthier than we are, why didn’t they live longer and produce more offspring? The Post interviewed anthropologist Kenneth Sayers, who pointed out that hunter-gatherers didn’t live much beyond reproductive age. Hard to argue with his analysis: “[I]t’s hard to be healthy when you’re dead.”

Like most food trends, the paleo diet isn’t all about health or science, it’s mostly about nostalgia and the sense that the more “natural” diet of the past, whether it’s 150 years ago or 2 million, is somehow superior.

Evolution isn’t a process toward perfection, it’s a process of adaptation, of trade-offs and compromise. Walking upright, for example, enhances mobility but makes it harder to give birth and predisposes people toward back pain.

As Marlene Zuk, an evolutionary biologist, said, “It’s not like bipedal humans should have said, ‘Wait, wait! Stay in the trees!’”

Lieberman said that the paleo diet makes unscientific assumptions about what our ancestors ate. There wasn’t a single paleo diet, but many. Stone Age people lived in diverse habitats, from the tropics to the tundra, and just like you can’t shop at Trader Joe’s in Alaska, the paleos couldn’t get reindeer in the rainforest.

“There is no one time and place and habitat to which we’re adapted,” Lieberman said.

We have adapted to living in a wide range of habitats, so it follows that we would eat a wide range of foods. We’ve also “adapted” to a less active lifestyle than our hunter-gatherer ancestors. To recommend a modern diet based on what we believe paleolithic humans ate ignores the role of activity in metabolism and digestion.

Still, like many trendy diets, aspects of the paleo diet aren’t without a health benefit. Less sugar and, especially if you’re not very active, fewer calories are good ideas. But unless you have difficulty digesting milk sugar (lactose intolerance), rejecting dairy products isn’t usually a matter of health, but preference. The ability to metabolize milk evolved a long time ago, so paleo diet claims that humans aren’t meant to eat dairy products is just wrong. Dairy products consumed in moderation can be a valuable part of a nutritious diet.

And it isn’t true that the paleolithics didn’t eat grain. Hunter-gatherers in the Middle East ate wild barley, and used mortars and pestles to grind it into flour.

So if you like the paleo diet, enjoy. But remember, it’s not necessarily superior in terms of health benefit to other well-balanced diets. It’s just trendier.

To learn more about healthful eating, see our blogs about nutrition, and Patrick’s newsletters on the Mediterranean diet, saturated fat, and supplements and sports drinks.

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March 19, 2015

FDA Approves New Class of Drugs

Consumers and health insurers usually welcome the advent of generic drugs because they lower the cost of expensive brand name medicine and generally have the same therapeutic effect. Earlier this month, the FDA approved the first copycat drugs that aren’t exactly the same, but are essentially so, thus introducing alternatives to whole classes of drugs whose brand exclusivity can be protected for years.

“Biosimilars will provide access to important therapies for patients who need them,” said FDA Commissioner Margaret A. Hamburg in a statement quoted by the New York Times.

The approval is for a class of drugs called “biologics,” which are made from living cells or tissue, not chemicals synthesized in a lab, like most drugs. Their active ingredients are impossible to replicate exactly, so their copycats are called biosimilars, not generics. They don’t infringe on patents because you can’t patent cellular material.

Pharmaceutical companies generally spend years and millions of dollars developing traditional drugs, which is why those brands are protected from competition for so long — the idea is to encourage this investment of money and resources to spark innovation for which there’s no guarantee the results will be successful and a company’s bottom line enhanced.

The process is ripe for abuse by the pharmaceutical industry, which loves to champion its efforts to develop new drugs for needy patients, but also likes to stick them with huge bills while ignoring the fact that they spend billions promoting them and lobbying Congress for special treatment. Reasonable minds wonder why they don’t cut costs for consumers if they have so much money for bold claims they can’t always support. (See our blogs about legal problems for drug makers whose business plans include stretching the truth.)

As The Times pointed out, some of the most expensive drugs in the world are biologics; you might have heard of Remicade and Enbrel, which treat some kinds of arthritis and other autoimmune disorders, and Herceptin and Avastin, which treat certain cancers.

The specific biologic approved by the FDA is Zarxio, which treats infections in cancer patients who are getting chemotherapy. It’s made by Sandoz, and is based on Neupogen, which is made by Amgen. Patients in Europe have been able to take Zarzio since 2009, but because the U.S. had no regulatory process for allowing the marketing of biosimilars, it hasn’t been available here.

The feds approved Zarxio for all the uses of Neupogen, and permitted its label to carry nearly identical language.

In countries where they are sold, biosimilars are about one-third less expensive than their brand-name biologic models, according to Express Scripts, the largest prescription drug benefit manager in the U.S. Some experts believe that discounts could be as high as 90%, and Express Scripts, said The Times, estimates that U.S. Zarxio consumers could save $5.7 billion in drug costs over the next 10 years, and that $250 billion in drug costs could be saved in that period if 11 biosimilars now in development were approved.

Biologic drugs entered the scene in the 1980s and, The Times explained, were thought to be so specialized that making generic versions wasn’t possible. But science has advanced. You can’t make exact copies of the active ingredients, as traditional generics strive for, so biosimilars don’t replicate the raw materials, but they come close in terms of the therapeutic effect.

Amgen is trying to block the sale of Zarxio, claiming that Sandoz did not follow the rules about of informing Amgen in advance of its plans for the drug, which Sandoz denies. But it said it would refrain from selling Zarxio until a decision is made on the injunction or April 10, whichever comes first.

No one should be surprised that Amgen told the Los Angeles Times that it, too, hopes to capitalize on the biosimilar market and start making its own copies of other companies’ biologics. It doesn’t like other companies capitalizing on a new market, but that’s not going to stop it from doing so.

Even if they’re less expensive, maximizing use of the new class of drugs faces some challenges. Generic drug companies don’t rely on marketing to sell their wares, but on pharmacists to substitute the generic for a brand-name drug, and on insurance companies to entice policyholders with better coverage for generics. But this standard substitution can’t automatically happen with biosimilars, at least not yet.

So, The Times suggested, makers of biosimilars might have to market them to doctors to boost prescription numbers, and persuade insurers to use them as the default drugs, as they do generics.

And although marketing biosimilars is new, they still have some competition. Teva sells a copy of Neupogen, called Granix, but it was approved via the process for a novel drug, not as a biosimilar. And Amgen sells a longer-lasting version of Neupogen (Neulasta) that requires fewer injections and might be preferred by patients and doctors, even if it costs more.

The FDA’s approval also raises the question of what to call biosimilar drugs. Some generic drug makers and insurers want biosimilars to have the same generic name as the branded product, because that would make it easier for doctors to use them as substitutes. But some biologic manufacturers want different names in order to make it easier to trace a drug’s side effects to its specific manufacturer.

The FDA, said The Times, sort of split the difference. “Instead of simply calling Zarxio filgrastim, the generic name for Neupogen,” The Times explained, “it called the drug filgrastim-sndz, the suffix standing for Sandoz, the manufacturer.”

To learn more about prescription drug options, see Patrick’s newsletter,“Becoming a Smarter Buyer of Prescription Drugs.”

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March 17, 2015

Why the Supreme Court Is Reviewing Obamacare

Earlier this month, the Supreme Court heard arguments that health insurance premium subsidies for people who receive coverage from the federal government’s new insurance exchange are unconstitutional. Unless you follow health-care policy, you might be unclear why the Affordable Care Act (ACA), which Congress passed in 2010 and is responsible for wholesale changes in insurance coverage, remains the subject of legal tussling.

This is the second time the high court has considered legal challenges to the law, and its decision will have a huge effect: If the court overturns premium subsidies for plans offered on, some 8 million people (depending on who’s crunching the numbers) in 34 states could lose their health insurance.

Courtesy of Associated Press (AP), here’s why “Obamacare” seems to be a never-ending drama.

Political Opposition

Although Obamacare is increasingly popular, and 10 million more adults now get health insurance than two years ago, conservatives (primarily Republicans) want to repeal the ACA, claiming that they will replace it with superior legislation. But the key is “repeal first, replace later,” which is less statesmanship and more political pandering to the forces that believe providing health care to more people, especially those who have pre-existing health conditions that made insurance either unaffordable or unavailable, is somehow un-American.

One big provision of the ACA is that insurance companies may not refuse to cover people because they’re sick. It also requires plans to cover certain preventive services free of charge, and allows children to be covered under their parents’ plan until they’re 26.

“A Supreme Court ruling invalidating the law's subsidies in most states,” AP explained, “would give Republicans their best opening yet [to repeal and replace Obamacare].” Of course, the Republicans talk less about the fact that "replacement" legislation also would cost taxpayers dollars and generate more federal regulations than they do about the law’s language they say excuses the feds from subsidies.

Not all Republicans support wholesale changes in the ACA; some Republican governors, for example, have accepted the law's Medicaid expansion for low-income people, but generally, Republicans in Congress remain staunchly against Obamacare.

The Obama Administration Messed Up

In promoting passage and popular support of the ACA, President Obama claimed that if you liked your health plan you would be able to keep it. After it passed, a wave of insurance plan cancellations blamed on the health law’s requirements proved that statement not to be true for everyone.

Then, when went live, it was balky, when it worked at all. Making it the useful tool it was supposed to be for signing up for insurance coverage took months.

Later, after widespread objections by small and medium-sized businesses, the administration said it would postpone implementing a major requirement for them, but did so on an obscure government blog just days before the Fourth of July. And an online insurance market geared to small businesses has disappointed users.

Earlier this year, sent the wrong tax information to about 800,000 people, giving more fuel for critics who wonder if this program does anything right.

Some of these issues might be expected with such a significant change in the provision of health insurance, but the routinely clumsy way problems weren’t handled was a PR nightmare.

Writing Versus Assembling Legislation

“The Affordable Care Act did not get the legislative equivalent of close editing by a House-Senate conference committee,” AP stated.

The patchwork approach to writing major legislation pretty much guaranteed that problems would be packed into the law’s 900 pages, which were compiled by different congressional committees working on different parts of the bill.

After the law was signed, for example, its vague wording about guaranteeing coverage to children with pre-existing health conditions had to be clarified through regulations after the insurance industry acquiesced to them.

“The path to passage may be at the root cause of the current dispute before the Supreme Court,” said AP, “which centers on whether the wording of the law allows federal subsidies in states that don't set up their own insurance markets.”

As Justice Antonin Scalia observed, “It was pushed through on expedited procedures and didn't have the kind of consideration by a conference committee ... that statutes usually do.”

Costs of Care

Last week, as The New York Times reported, the Congressional Budget Office (CBO) lowered its estimate of the cost of the ACA, saying that the cost of health insurance premiums wasn’t growing as much as anticipated. The CBO reduced its estimate of the 10-year cost of federal insurance subsidies by 20%, as well as its estimate of new Medicaid costs attributable to the new law.

That’s good news for Obamacare and for consumers, but health care is still expensive, as is insurance for it. Although premiums are heavily subsidized, AP pointed out, people who buy private coverage through the new insurance markets (that is, they aren’t covered through employer plans) still might struggle with costs.

Out-of-pocket expenses, including the annual deductible and required copayments, AP reported, can reach $6,600 for an individual and $13,200 for a family. If someone has a serious illness, a family earning $60,000 a year might have to spend more than 20% percent of that amount just on medical bills.

Average monthly premiums rose by 8% this year in states served by — that is, those without their own exchanges. After subsidies, the average monthly premium consumers pay directly increased $23 a month.

It’s Darn Complicated

Obamacare married two of the most complicated facts of life for consumers: health insurance and taxes.

“Even now, in the second year of coverage,” according to AP, “enrollment counselors say many consumers get overwhelmed trying to understand what plan is best for them. It can be hard to figure out which doctors are in what plans, and what is the patient's share of the cost for a particular medication.”

Yep. It’s like trying to become your own car mechanic if you don’t know a timing belt from a belt of scotch. Consumers, many of whom are used to employer-provided coverage that gives them few, if any options, or people who’ve gone uninsured either because they couldn’t afford insurance or chose to play the percentages that they wouldn’t need it, are being asked to educate themselves in sometimes difficult material.

That learning curve gets steeper thanks to the connection between the ACA and the tax system, which is used to deliver carrots and sticks. Premium subsidies are considered tax credits, and consumers who qualify for them must demonstrate to the IRS that they received the right amount per their income. People who are deemed over-subsidized will have to pay back the surplus, and those who weren’t subsidized enough will get tax refunds. People who remained uninsured will be fined in the form of deductions from their tax refunds, if they are determined to be able to afford coverage.

If these challenges to the smooth implementation of the Affordable Care Act seem overwhelming and impossible, if it seems like the legal and political wrangling can never end, consider the enormity of what’s being attempted — people who could never afford health insurance now can, even though it’s difficult to understand may be less than excellent, and costs for it should diminish as the pool of people with coverage increases.

That is never a bad thing.

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March 16, 2015

A Big Step for Civil Justice

Good news last week about protecting consumer rights. As spelled out by, the civil justice website, a large study supported by the federal government concluded that forcing individual credit card, bank and other financial/product services customers to agree to arbitration and forgo their class-action rights in the event of a dispute prevents righteous lawsuits from being filed.

The Consumer Financial Protection Board’s study was 700+ pages of evidence that these forced “agreements” amount to a system rigged to benefit corporations. At the expense, of course, of real people. (See our blog, "Arbitration Agreements: Bad for Consumers, Good for Nursing Homes.")

As PopTort explains, because “most cases are too expensive and difficult to bring individually, these clauses plus class action waivers result in the disappearance of claims and immunity for the wrongdoer.”

Study highlights include:

  • Forcing people to sign repugnant contracts is widespread. For example, almost 9 in 10 mobile wireless providers who authorize third parties to charge consumers for services have arbitration clauses. Such providers cover nearly 100% of the market.

  • Most people who are forced into arbitration or prevented from filing as a class give up their claims. Of tens of millions of consumer financial contracts, only about 600 arbitration cases and 1,200 individual federal lawsuits happen every year versus, on average, about 32 million consumers eligible for relief through class-action settlements in federal court.

  • Contrary to widespread misinformation that class actions benefit only attorneys, the CFPB found that “settlements totaled $2.7 billion in cash, in-kind relief, expenses and fees,” and that only about “18% of that [went] to attorneys’ fees and expenses.”

  • The CFPB also noted that those figures don’t reflect the potential value to consumers of companies changing their behavior. In the cases for which data was available, at least $1.1 billion was paid or scheduled to be paid to at least 34 million consumers.

As PopTort summarized, the misguided and unfair movement for “tort reform” has raged for decades. And its claims that such “reform” is necessary to prevent frivolous lawsuits, and enriching lawyers at the expense of just folks, have been proved wrong.

“Look at the area of medical negligence,” PopTort advised, “where preventable errors are at epidemic levels – the third leading cause of death in America. Ninety-nine percent of the time, there is no claim or legal accountability. If jury verdicts are severely limited by law, lawyers paid on contingency cannot afford to take many of the most serious and costly cases. And as any trial lawyer who has to turn away 100 cases for every 1 they take knows, most people have no idea that lawmakers have stripped away their rights – or even that they may have voted to give up their own rights, convinced by fabrications and fear-mongering by industries seeking immunity.”

The CFPB study is a big first step in the right direction of banning forced arbitration clauses and class-action waivers. Another positive development occurred last week, when a judge in Tennessee ruled that that state’s cap on economic damages in personal injury cases is unconstitutional.

As reported in the Insurance Journal, in 2011, the Tennessee Legislature limited the amount of money for a personal injury judgment. Noneconomic damages include pain and suffering, disfigurement or scarring and loss of enjoyment of life. In most cases, the cap for noneconomic damages is $750,000.

If you’d like to contribute to the effort to protect your rights as a consumer sign the petition, and as a potentially harmed patient, hope that tort reform laws get the same kind of attention as financial services contracts.

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March 15, 2015

Better Late Than Never: Gynecology Guidelines Are Issued for Robotic Surgery

Although increasingly popular, robotic surgery has been shown to be risky and expensive, so guidelines for its use issued recently by the American Congress of Obstetricians and Gynecologists (ACOG) and the Society of Gynecologic Surgeons (SGS) should be required reading for anyone considering the procedure.

Promoted as a minimally invasive procedure for a wide range of problems involving many different body parts, robotic surgery is performed by a surgeon directing remote-controlled instruments from a console, often working in spaces smaller than human fingers can access. But in addition to causing problems such as burning and bleeding that are complicated by surgeons’ lack of training and conflicts of interest, robotic surgery is more expensive than more traditional surgical procedures, and the outcomes are equivalent.

As the ACOG report said, “Initially developed for battlefield medicine, robot-assisted surgery was approved by the [FDA] 1999 for urologic and cardiac procedures and in 2005 for gynecologic surgery. Today, robot technology is applied widely in gynecology for hysterectomy, sacrocolpopexy [repair of prolapsed, or slipping, pelvic organs], myomectomy [removal of uterine fibroids], adnexal surgery [appendages of the uterus] and malignancy staging [determining how far cancer has progressed].”

Robot-assisted surgery, said ACOG, is performed at more than 2,000 academic and community hospital sites in the U.S., and its use is growing annually by more than 25% annually. It’s no coincidence, as we’ve written, that use of surgical robotic equipment has grown in tandem with hospitals’ purchase of it — it’s a profit center, and it’s heavily marketed by the hospitals that own it and the industry that sells it.

Too often, we’ve noted, patient safety has fallen through these growth cracks, and now at least some professional medical organizations are addressing it. As the ACOG report stated, “Hospitals and physicians actively advertise and promote robotic surgery programs, often with unsubstantiated claims of improved outcomes and patient safety. The purpose of this Committee Opinion, developed by the [Congress] and SGS, is to provide background information on robot-assisted surgery for gynecologic conditions, review the literature on this topic and offer practice recommendations.”

Solid scientific data about robot-assisted surgery is sorely missing, and ACOG/SGS wants to improve that situation, too — after all, you can’t (or shouldn’t) set policy if you don’t have an evidence-based foundation for it. Although the recommendations are an example of how fact chases desire, at least they’re better late than never.

Specifically, ACOG/SGS recommend:

  • Well-designed randomized controlled trials (RCTs) or comparably rigorous nonrandomized prospective trials to determine which patients are likely to benefit from robot-assisted surgery and to establish the potential risks.

  • Robot-assisted cases should be selected based on the available data and expert opinion. As with any surgical procedure, repetition drives competency. In addition to the training necessary for any new technology, ongoing quality assurance is essential to ensure appropriate use of the technology and patient safety.

  • Adoption of new surgical techniques should be driven by what is best for the patient, as determined by evidence-based medicine rather than external pressures.

  • Adequate informed consent should be obtained from patients before surgery. For robotic procedures, this includes a discussion of the indications for surgery and risks and benefits associated with the robotic technique compared with alternative approaches and other therapeutic options.

  • Surgeons should describe their experience with robotic-assisted surgery or any new technology when counseling patients regarding these procedures.

  • Surgeons should be skilled at abdominal and laparoscopic approaches for a specific procedure before undertaking robotic approaches.

  • Surgeon training, competency guidelines and standards to measure them should be developed at the institutional level.

For more information about surgical errors and gynecologic issues, see our respective backgrounders here and here.

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March 12, 2015

Try Teamwork to Avoid a Missed Diagnosis

A recent blog in reported that 1 in 20 U.S. adults might be misdiagnosed during an outpatient visit, and that about half of those errors eventually could cause harm. About 12 million U.S. adults experience a diagnostic mistake every year. Are they lapses in judgment? The result of rushed appointments? An inability to communicate?

You’d think after so many reports of such widespread medical error that researchers would have made a lot of progress scaling the learning curve of misdiagnosis.

A recent article in the Journal of the American Medical Association (JAMA) concluded that teamwork might be one approach to reducing the incidence of diagnostic error, a condition that’s missed, delayed or diagnosed incorrectly.

“When two doctors worked together,” summarized Modern Healthcare “their confidence in a diagnosis was boosted and their determination was more accurate.”

The study subjects were 88 fourth-year medical student volunteers. They were shown video of simulated patient cases, then asked to quickly determine which of 30 diagnostic tests should be ordered, and to select one of 20 possible diagnoses from a list. They also rated on a scale of 1 (least confident) to 10 (most confident) how certain they were of their conclusions.

Twenty-eight of the students worked individually and the rest worked in pairs.

The pairs took 2:02 minutes longer than individuals to make decisions, but they were more accurate in selecting a diagnosis (68 %) compared with the solo subjects (50%). And pairs expressed more confidence in their decision than the singles.

The sample was quite small, of course, and no broad or significant conclusions could be drawn from the exercise. But the results point the way toward more fruitful, definitive examinations.

“Neither differences in knowledge nor in amount and relevance of acquired information explained the superior accuracy of the pairs,” the authors wrote. “Collaboration may have helped correct errors, fill knowledge gaps and counteract reasoning flaws.”

As JAMA noted, the patient safety community is anticipating an Institute of Medicine (IOM) report later this year that's “expected to raise a red flag on diagnosis errors and give advocates the fuel needed to focus resources on addressing this cause of patient harm. The shift in healthcare toward value-based care models could help put systems in place that makes the diagnostic process more reliable, experts say.”

The IOM first raised the misdiagnosis consciousness in 1999, with its seminal report, “To Err Is Human.”

It seems to us that the team approach to diagnosis is just common sense. Talk to each other, doctors! And while you're at it, spend more time with the patient and their family.

Patients, their loved ones and any caregiver can contribute to the body of what’s-wrong knowledge. As Dr. Gordon Schiff, a diagnostic error researcher at Brigham and Women's Hospital in Boston, told Modern Healthcare in a longer story, “Physicians blame patient 'treadmill' for missed calls,” the idea that “this heroic, lone ranger thing the doctor does with the doors closed in their office” is romantic and outdated.

The story discussed the pressures that sow the seeds of our national landscape of diagnostic error. “While the U.S. patient-safety movement has focused enormous attention on medical errors over the past few decades, diagnostic errors have received less attention from practitioners, the research community or patient-safety advocates,” it read. “The extent of the problem is hard to assess as missed diagnoses remain a largely unreported phenomenon.”

Read the whole story to learn more about the ingredients of a major medical problem in our nation, and where we are in trying to solve it. Read Patrick’s current newsletter, “What to Do When the Doctor Doesn’t Know What’s Wrong” to see things from the provider’s perspective, and our backgrounder for general information.

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March 10, 2015

Former Patient Safety Advocate Settles Conflict of Interest Case

Last year we told the story of Dr. Chuck Denham, who went from a being a renowned patient safety advocate to being accused of accepting kickbacks for promoting drug company products while he was advising the National Quality Forum on best safety practices for medical providers.

Last week, as announced by, Denham agreed to pay $1 million to settle those allegations. The deal also bars him from participating in Medicare and Medicaid programs.

His was quite the fall from grace to disgrace.

The National Quality Forum (NQF) is a nonprofit organization whose work is considered first-rate for objectivity and sound science.

Denham polluted its well by failing to disclose to the panel of experts he led for its Safe Practices Committee that he had received payments from CareFusion Corp., which produces ChloraPrep, a surgical antiseptic. Other members of the panel had not planned to endorse the product, but Denham had encouraged it to do so. The committee ended up recommending ChloraPrep to prevent infections.

Denham’s lack of ethics undermined the integrity of the NSF and, according the U.S. Justice Department, prompted fraudulent claims to government health-care programs. Because he was responsible for what has been called the patient safety movement’s first scandal, Denham also was lopped as editor of the Journal of Patient Safety, which has accepted responsibility for its lapses in oversight. Denham has not acknowledged wrongdoing.

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March 9, 2015

Few Consequences Result When Health Data Is Breached

A recent investigation by shows not only that the medical community regularly abuses patient privacy, but that the responsible parties are seldom punished.

Since October 2009, more than 1,140 significant breaches of patient data have been reported by providers, organizations and their third-party associates. The information involved more than 41 million people, and pilfered in many ways, from stolen laptops, hacked servers and even paper records left unattended.

“Yet, over that time span,” ProPublica reported, “the Office of Civil Rights has fined health-care organizations just 22 times.”

Last year alone, the California Department of Public Health, which also levies fines against hospitals for compromising patient privacy, imposed 22 penalties; as of last month, it had imposed eight such penalties so far this year.

The Office of Civil Rights is authorized to audit health-care organizations to ensure they are protecting patient records, and to impose fines as high as $1.5 million per violation. Why is it so reluctant to protect people by exercising its authority?

The office, which has fewer than 200 employees and a budget of just $39 million, may use fine money for enforcement. Data security experts told ProPublica that the office lacks the resources to fulfill its oversight responsibilities, which each year also include reviewing more than 2,500 Medicare provider applications for civil rights compliance, more than 4,000 discrimination complaints and more than 15,000 claims of violations of the Health Insurance Portability and Accountability Act (HIPAA).

Anyone who has been in a doctor’s office or other medical setting since the late 1990s is familiar with the forms they’re given about their HIPAA rights. HIPAA mandates standards for the use and dissemination of health-care information, and directs how organizations must protect electronic medical records.

More than a decade after the passage of HIPAA, the Health Information Technology for Economic and Clinical Health Act (HITECH Act) required organizations to publicly report breaches involving at least 500 patients, and boosted the amount the feds could fine them for violating patient privacy and record security. It also directed the Health and Human Services Department (HHS) to conduct audits, and extended the rules to third parties affiliated with health-care organizations.

But in 2013, the inspector general faulted HHS for not performing audits mandated by the act after a pilot audit program in 2011 and 2012 showed that 102 of the 115 organizations reviewed had problems with security or weren’t following rules to safeguard patient privacy. Only now, according to ProPublica, are follow-up audits getting started.

The Office of Civil Rights reviews every data breach, no matter how large or small; years might pass before they’re resolved. Unnervingly, the number of large data breaches is growing, including the one recently discovered by health insurer Anthem that exposed the medical information of about 80 million people. Last year, according to ProPublica, 278 large breaches were reported; between 2010 and 2012, there were fewer than 200 per year.

At a privacy and security forum in December 2012, Leon Rodriguez, then-director of the U.S. Department of Health and Human Services’ Office of Civil Rights, said, “We’ve now moved into an area of more assertive enforcement.”

You shudder to think what would happen the office weren’t so assertive…

Protecting privacy isn’t just about securing data. Last month, one of the nurses who contracted ebola last year at the Dallas hospital that treated victims sued the facility’s parent company not only for treatment shortcomings, but, she claimed, because the hospital violated her federal privacy rights when it videotaped her without permission. After a dying patient was depicted on a TV show, legislation was proposed last month in New York to make it a felony to film people getting medical treatment without prior consent.

The feds declined to be interviewed by ProPublica, but in a statement repeated that it “aggressively” identifies and investigates “high-impact cases that send strong enforcement messages about important compliance issues.”

In May, it hammered New York-Presbyterian Hospital and Columbia University with fines of $4.8 million for failing to secure the electronic health records of 6,800 people. One doctor, for example, had tried to remove his personal computer server from a shared network, which sent very detailed patient records flying onto Web search engines. The data flood was discovered when somebody found a deceased partner’s personal health information online.

It took five year for the feds to impose an $800,000 fine against Parkview Health System after 71 cardboard boxes of medical records of as many as 8,000 patients were left unattended in the driveway of a physician’s home. Remarkably, the incident wasn’t reported by the facility as a large data breach, but by the physician.

Some organizations told ProPublica that they didn’t know the status of their cases. One was the state of Utah, which reported in 2012 that hackers had gotten data on Medicaid and children’s health insurance claims, and that the Social Security numbers of 280,000 people were captured.

In the meantime, to its credit, Utah’s Department of Technology Services has increased security and funding, now monitors its network 24 hours a day and conducts an outside security assessment every two years.

Industry experts contacted by ProPublica said that the Office of Civil Rights is trying to catch more flies with honey than poison them with vinegar. They said the feds are working with organizations to improve their security and punishing only the worst lapses. Providers often voluntarily agree to make necessary changes if they’re not fined, the feds said.

How often have product manufacturers agreed to adhere to voluntary standards, only to fall short if no one’s making sure they do? How often have pharmaceutical companies merely paid fines as the cost of doing business for the dangerous false advertising of their drugs?

Some security experts told ProPublica that the government must flex its fining muscles to address the wave of patient data breaches. One such expert compared the situation to environmental pollution.

“If the cost of polluting is zero, companies will pollute,” he said. “How would a rational company not do that? If your CEO said we’re going to spend four times as much money not to pollute, he would be fired. What you need is to make security rational.”

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March 8, 2015

Concierge Medicine Company Found Liable for Doctor’s Malpractice

The practice of “concierge” medicine has grown recently, thanks to doctors who are frustrated with the intrusive bureaucracy involved in the usual delivery of medical care, and patients with enough money to pay annual retainers for better access to them.

Now, this new-ish form of medical business is on the paying side of what is believed to be the first malpractice jury assessment. Last month, (KHN) reported on a lawsuit against MDVIP, the nation’s largest concierge medicine practice, and the jury’s $8.5 million verdict for the plaintiff.

MDVIP, which includes nearly 800 affiliated physicians in 41 states, was founded 15 years ago. Patients pay a $1,500 annual membership fee in exchange for faster service and more attention from their primary care doctor, but the fee doesn’t necessarily cover the full costs of care; as usual, those depend on each patient’s problem, and his or her insurance coverage. Some concierge doctors don’t accept insurance.

In the lawsuit, which was tried in Florida, MDVIP was found liable for the negligence of one of its physicians, who was sued by the patient’s family for misdiagnosing her leg pain. Despite the pain getting progressively worse, the physician and other MDVIP-affiliated staff repeatedly misdiagnosed the cause. The patient was referred to orthopedists who said they had not gotten her medical records or learned about the worsening symptoms.

With the benefit of that information, her serious circulation problem might have been discovered before it got so bad that her leg had to be amputated.

In addition to finding the MDVIP liable for that disastrous outcome, the jury also decided that it had falsely advertised the nature of its “exceptional” care.

As explained by KHN, “Industry experts say the ruling is significant because it shows concierge companies can be held liable for the care provided by their contracted doctors. The companies typically argue they do not actually provide care but merely act as brokers between doctors and patients.”

An official with the American Academy of Private Physicians, a trade group of concierge doctors, told KHN that the judgment shows that concierge companies “have a legal risk that everyone assumed did not exist.”

The primary care doctor had settled a lawsuit with the patient’s family before the MDVIP trial. The company had claimed that because its physicians were not employees, but contractors, it was not responsible for their actions. Doctors affiliated with the company pay it fees for marketing, branding and other business development services.

One of the plaintiff’s attorneys said the verdict will ensure that concierge companies exercise more oversight about the doctors with whom they affiliate, and that they will be more careful about their advertising claims.

Another attorney who practices health-care law but who was not involved in the MDVIP case called the verdict “shocking,” and agreed that it would prompt concierge companies to examine their promotional claims.

But MDVIP plans to appeal the decision, and one consultant for the concierge medical industry was skeptical that this single verdict, significant though it is, will have a long-term effect.

KHN estimates that 6,000 doctors in the U.S. have adopted concierge-style practices in the last 15 years, and the trade group said the number has doubled in the last five years.

An executive with the concierge trade group told KHN that the industry generally has a good track record, noting that although concierge physicians are not immune from malpractice suits, they’re less likely to be sued because they spend more time with patients than most doctors.

He has a point; as we’ve written, strong doctor-patient communication is key to good care, and you can’t communicate well when you’re treating by stopwatch. In order to have sufficient time for good care, concierge physicians generally limit the number of patients they treat; MDVIP’s limit is 600 compared with a few thousand for a traditional practice.

So money — retainer fees — can buy more time with the doctor. But shouldn’t everybody, not just those who can afford it, be able to take the time necessary to improve and maintain their health?

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