DC Medical Malpractice & Patient Safety Blog

June 28, 2017

Here’s why you’re getting those unsolicited mailings about clinical trials

When consumers around the country started getting letters from a company that they had never heard of, inviting them to participate in clinical trials for medical conditions that they hadn’t disclosed to many or didn’t even have, the alarms started to sound, quietly at first but with increasing urgency. Were doctors, hospitals, or other providers breaching medical privacy laws? Had there been a serious but unpublicized leak or unwelcome disclosure of patient data?

Kudos to the information site Buzzfeed for digging in and finding out how Acurian Health, a firm with an address in a rural county outside of Philadelphia, exploits state-of-the-art Internet marketing and data-mining techniques to learn, in creepy fashion, about Americans and their illnesses.

It does this by buying marketing information that a range of companies collect on customers, some of it volunteered and others extracted from data points like zip codes, purchasing patterns, and available demographics: Do you live in an upscale or modest neighborhood? Are you and your neighbors most likely to be highly educated professionals or blue-collar laborers?

June 27, 2017

Why do drug prices soar? Blame PBJs, PBMs, weak regulators, and CME

by Patrick A. Malone

What do PBJs, PBM “black boxes,” industry friendly advisory panels, and CME (aka doctor training programs) all share in common? They’re blamed for contributing to Big Pharma’s skyrocketing prices—and it’s worth diving into recent reports on these disparate causes to understand how Americans got into such dire shape with the costs of their medical care.

Let’s start with peanut butter and jelly sandwiches and a little math. A jar of generic peanut butter might cost a bit more than a buck and change, with a jar of strawberry jam running about the same. Now if you buy them in a combined product—Smucker’s version is called Goober—it sets you back $3.49.

This pricing comes from Marshall Allen, a reporter for Pro Publica, a Pulitzer Prize winning investigative news site. He goes on to compare PBJs with a medication his orthopedist recently prescribed for him: Horizon Pharma’s Vimovo. It’s a non-steroidal anti-inflammatory drug (NSAID). Allen points out it also is little more than a combination of the pain-reliever naproxen (best known in the branded version Aleve) and the upset-stomach remedy esomeprazole magnesium (best known as Nexium). He could walk into a drug store and buy a month’s supply of both for $40.

June 25, 2017

GOP senators’ Trumpcare: Meaner in many ways than even House plans

by Patrick A. Malone

After weeks of huddling in partisan secrecy, majority Republicans in the U.S. Senate have coughed up what they’ve dubbed the Better Care Reconciliation Act , aka their version of Trumpcare.

In brief, the GOP Senate bill would:

Slash Medicaid, faster and more than the House version, aka the American Health Care Act

June 23, 2017

Obesity spreads as global bane, afflicting 604 million adults, 108 million kids

by Patrick A. Malone

Although weight issues plague Americans as gravely as anywhere on the planet, obesity also has become a global woe, increasing sharply over the last three decades in 195 countries and afflicting an estimated 604 million adults and 108 million children—roughly 10 percent of the world’s population.

No nation on earth, even with the terrible toll that obesity takes in economic and health terms, has found a way to get its people skinnier and healthier: Weight woes are blowing up in disparate places like Saudi Arabia, Algeria, Egypt, Burkina Faso, Mali, and Guinea-Bissau, international researchers have reported in the New England Journal of Medicine. Obesity is now a major concern, too, for the people of China, Turkey, Venezuela, and Bhutan.

Public health experts worry about the skyrocketing numbers of overweight people around the planet because evidence shows obesity to be a major factor in heart disease, diabetes, cancer, and other debilitating conditions. These afflictions, combined with weight issues—including among those considered to be too heavy but not necessarily obese—contributed to four million deaths in 2015 alone, said the experts, participating as part of the Global Burden of Disease initiative.

June 22, 2017

Big Tobacco, preying on poor and uneducated, also hikes health inequities

by Patrick A. Malone

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Although most Americans finally may be breaking out of cigarette smoking’s killer grip, Big Tobacco keeps inflicting terrible harm on some of the nation’s most vulnerable—the poor, uneducated, and those who live in rural areas.

The federal Centers for Disease Control has just offered its annual assessment on Americans’ smoking habits, providing some rare good news about most of us and especially kids: Cigarette smoking among the nation’s youth is diving to new lows, and the use of smokeless or e-cigarettes for “vaping” showed its first declines.

Anti-smoking campaigns may be working, persuading teens and many adults to avoid smoking or to quit the bad habit that has been proven to cause cancers and to contribute to heart disease and other damaging conditions, the CDC says. The agency also notes that youth vaping and smoking may have declined due to new age-based restrictions on product sales and advertising.

June 20, 2017

Uncle Sam’s bad reverse: nursing homes returning to forced arbitration

by Patrick A. Malone

Look out Baby Boomers and Gen Xers: Just when you or your elderly loved ones may be most vulnerable and needing nursing home care, the government is going back to allowing nursing home administrators to push a pile of documents for you to sign at you at admission time. And when you put your John Hancock on some of these, you will give away important legal protections.

The Centers for Medicare and Medicaid, overseer of 1.5 million nursing home residents and more than $1 trillion in Medicare and Medicaid funding, has posted notice that, under Trump Administration leadership, it soon will reverse its predecessors’ plan to halt agreements that forced patients and their families to give up their right to sue. Instead, Trump officials will push them to the alternative legal process known as arbitration. Officials insist they will require nursing homes to make arbitration requirements simpler, and to ensure they’re written in plain English.

But, in keeping with a recent U.S. Supreme Court ruling in a Kentucky case, regulators are yielding to the nursing home industry’s aggressive lobbying and point of view that arbitration is simpler, easier, and will keep down costs.

June 18, 2017

What’s the Senate hiding on health care bill?

by Patrick A. Malone

Bernie Sanders recently offered on Twitter what he described as a display of all the Senate Republicans’ public considerations of the American Health Care Act, aka Trumpcare: a photo of a blank piece of paper.

Not a bad jibe, and a window into the deepening bipartisan dismay that Majority Leader Mitch McConnell and his Republicans soon will try to jam through the next step in their long-sought effort to repeal and replace the Affordable Care Act, aka Obamacare.

Does McConnell have the 50 votes he needs so Vice President Pence can break a Senate tie and move Trumpcare closer to reality? Will this occur in just days, before Congress heads to its July Fourth recess? Or will it happen in the small period before the long August recess, when Trump Administration officials also want Congress to take up an increase in the debt ceiling and to tackle a budget and maybe some tax law changes?

June 16, 2017

Bicycling injuries, medical costs rise as older, male riders crash with cars

by Patrick A. Malone

As more Americans try to stay healthier and to beat the pains of commuting by car, bus, or light rail systems, many (including yours truly) have turned to bicycling. But as a result, non-fatal bike injuries have skyrocketed—especially for men and for riders older than 45—and two-wheel collision treatment has become expensive: The annual cost of medical care for bike crashes in 2013 alone exceeded $24.4 billion, double the amount for all occupational illnesses.

Those are findings of a multi-year study (1997-2013) of electronic records on 3.8 million non-fatal and 9,839 bike-related deaths, research published in Injury Prevention, an online specialty journal.

A key reason why the cost of cycling wrecks—including for emergency transport, hospital charges, rehabilitation, nursing home stays, and lost work and quality of life—has raced upwards: Bikers more than ever are mixing it up with cars on streets. Road collisions accounted for just under half of biking injuries in 1997. They’re almost two-thirds of such wrecks now.

June 14, 2017

A new infectious threat at hospitals & nursing homes: deadly Legionnaire’s

by Patrick A. Malone

Hospitals and nursing homes, by failing to properly maintain their water systems, may be putting older patients at high risk of an unusual form of pneumonia, with federal officials tracking 1 in 5 suspected or confirmed cases of life-threatening Legionnaire’s Disease to health care facilities.

Anne Suchat, acting director of the Centers for Disease Control and Prevention, has urged caregivers to redouble their efforts to stamp out Legionella bacteria contamination in areas where poor maintenance may allow infections to flourish, including in water storage tanks, pipes, cooling systems, showers, sinks, and bathtubs. She said Legionnaire’s cases were too widespread, “deadly … and preventable.”

CDC researchers analyzed 2,809 of 6,079 Legionnaire’s cases nationwide in 2015 alone. They found 553 cases in 21 different and targeted jurisdictions, including Virginia, definitely or possibly occurring in a nursing home or hospital. The infections caused 66 deaths.

June 12, 2017

FDA can’t ignore oversight of drugs, medical devices once on the market

by Patrick A. Malone

Big Pharma and medical device makers have opened their wallets for a 2017 lobbying spree, throwing tens of millions of dollars around the nation’s capital, including to campaign with lawmakers and regulators to defend their soaring prices and to speed the path for their products to get to markets. But credit’s due to officials and organizations like Stat, the online health information site, for building a greater urgency behind a different narrative: It may be as crucial to monitor and regulate drugs and medical devices after they’re publicly available as pre-approval.

A two-part Stat report, aptly titled “Failure to warn,” dismantles existing oversight of prescription medications, especially regulators deeply flawed, big-data driven initiative dubbed Sentinel. The eight-year-old, $207 million program is supposed to mine insurance records to surface side-effects of drugs recently approved by the federal Food and Drug Administration.

But by examining 500,000 reports of side-effects from drugs targeted at the 1.5 million Americans with debilitating rheumatoid arthritis, Stat shows Sentinel’s shortcomings with Roche’s billion-dollar RA product Actemra. The FDA has received 1, 128 reports, complaining about patients who have died while taking it. But the agency, Stat says, “doesn’t have sophisticated tools to determine whether the drug was a culprit or a bystander in those deaths.”