Articles Posted in Pain

actemraBig 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.”

ohio-300x185With more than 4,000 overdose deaths last year alone and a fifth of its residents having received prescriptions for powerful painkillers, the state of Ohio has sued five Big Pharma companies, accusing them of mispresenting opioid drugs’ risks and fueling the medications’ epidemic abuse.

Ohio joins Mississippi in suing makers of increasingly lethal drugs like OxyContin and Percocet, whose addictive nature was hidden and downplayed by Big Pharma, critics say. The abuse of prescription opioids has fueled heroin use, with 33,000 Americans dying last year alone due to overdoses, federal and state health and law enforcement officials have said.

Fatal drug overdoses now exceed gun- or vehicle-deaths and they are matching the terrible tolls exacted at the height of the HIV-AIDS pandemic. Heartland America, and particularly white men, have been hard hit by the opioid drug crisis, with Ohio, Kentucky, New Hampshire and West Virginia recording the nation’s highest numbers of overdose deaths.

Blausen_0601_LaparoscopicGastricBanding-300x300They once got a ton of hype with radio, TV, and print ads, as well as billboard campaigns by proponents who later proved to be nothing less than sketchy. But the much-touted lap-band weight surgeries have fallen out of favor. The number of the procedures performed annually has nose-dived.

Researchers, based on a longer view, are finding that, among bariatric weight-loss options, lap-band surgeries offer some of the poorest results and result in frequent added procedures—at big costs, both economic and to disappointed, suffering patients.

Vox, the online news site, deserves credit for pulling together a painful review of what once was the most common way for overweight Americans, mostly women, to tackle one of the nation’s epidemic conditions: obesity.

nih_header-300x72Although its battles over health insurance have dominated the headlines, Congress also provided a glimmer of good news on funding for medical research. Lawmakers, at least for this fiscal year, shunned President Trump’s request to slash the budget of the National Institutes of Health. Instead of giving it the billion-dollar haircut the Administration sought, Congress boosted the NIH budget by $2 billion for the five months left in the current fiscal year.

The added fiscal support will be a boon for important research on: cancer, Alzheimer’s, precision medicine, the brain, and the battle against superbugs.

I’ve written how Congress earlier had, with much fanfare, decided to set aside partisan concerns to provide a steady increase in medical science research, which has been budget starved for some time. But the president had demanded cuts across the board, particularly so he could hike the appropriations for areas like the military and homeland security—notably his much promised border wall with Mexico.

Knee-300x166Hip and knee replacements, especially among seniors, have become so prevalent that almost 7 million Americans by 2010 had undergone the surgeries. With the cost to Medicare of knee replacements running between $16,500 and $33,000, and with roughly half of the procedures’ expense occurring post-operatively, there’s some good news for patients on saving money—and staying safer too.

Patients may want to get themselves out of the hospital and stay out of in-patient rehab centers in favor of well-planned, careful recuperation at home, studies show. The research focused on single adults living alone, and whether they fared better over the short- and long-term by rehabbing from total knee and hip replacements at skilled nursing facilities or at home, particularly if their home care was well considered and followed through.

They did at least as well and were happier recuperating at home, researchers found, adding that they also may have been safer: That’s because a third of patients in rehab facilities suffered adverse events in their care, a rate comparable to unacceptably high hospital harms and those in skilled nursing facilities.

codeineWhen severe colds, flu, or other infections run down youngsters with bad aches or an unrelenting hack, worried parents and doctors may turn to potent painkillers and cough suppressants. But the federal Food and Drug Administration has issued its strongest warnings about key ingredients in some of these, saying kids should not receive medications containing codeine or tramadol.

Both are powerful opioid painkillers. Prescription cough syrups often contain codeine. Tramadol typically is a drug given only to adults, though the FDA says it is seeing it prescribed more often, off label, to kids. Both tramadol and codeine have been prescribed for post-surgery pain for youngsters who have had their tonsils or adenoids removed.

But children, especially those 12 and younger, can have severe reactions to codeine and tramadol. They can slow or labor their breathing.

rheumatoid-arthritis-hands-2-300x200More than 50 million Americans struggle with arthritis: Three in 10 of them find that stooping, bending, or kneeling can be “very difficult.” One in five can’t or find it tough to walk three blocks, or to push or pull large objects. Grown-ups with arthritis are more than twice as likely to report fall injuries.  Arthritics have lower employment rates, and a third of them 45 and older experience anxiety or depression. So what to do about this leading cause of disability, a painful condition whose woes will only grow as the nation ages and already is responsible for $81 billion in direct annual medical costs?

Experts from the Centers for Disease Control and Prevention recommend that those with the most common arthritis forms—osteoarthritis, rheumatoid arthritis, gout, lupus, and fibromyalgia—avoid a reflexive reach for pain-killing pills. Instead, they must keep moving. “Physical activity,” CDC experts said in a new study, “is a proven strategy for managing arthritis. …” It also “has known benefits for the management of many other chronic conditions” that also afflict those with arthritis—including heart disease, diabetes, and obesity.

Although arthritis commonly is associated with seniors, the majority of adults with the condition, more than 32.2 million Americans, are younger than 65. Arthritis is much more common among women than men, and much less so among Hispanics and those of Asian descent that among whites. It afflicts those with a high school or less education more than those who completed college or higher.

Back-Pain-300x188Back pain is one of Americans’ leading debilitating complaints, prompting us to spend billions of dollars annually for relief and costing more than $100 billion, especially in lost work and wages. But an influential physicians’ group, joining a growing number of other experts, now recommends that we buck up, exercise, keep moving—and stay away from a reflexive reach for drugs, especially powerful painkillers, to deal with aching backs.

The American College of Physicians, with guidelines published in the Annals of Internal Medicine, concedes it is breaking with longstanding medical views on treating low back pain. But the group’s experts said they conducted a “systematic review of randomized, controlled trials and systematic reviews published through April 2015 on noninvasive pharmacologic and nonpharmacologic treatments for low back pain.”

They found that many patients with low back pain recovered over time “regardless of treatment,” and these individuals might benefit most from heat, rest, exercise, and over the counter, non-steroidal medications. Another group of back pain sufferers might need physical therapy, stress reduction, acupuncture, yoga, or ta-chi. Only after patients have not found relief with “non-pharmacological therapy,” should doctors consider giving non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen. If these don’t work, tramadol (Cymbalta) or duloxetine (Ultram) might be considered.

prescription-bottles-1-300x170Some diligent, grown-up sons and daughters may want to check in on mom, dad, and grandma, grandpa, all the aunties and uncles, too. That’s because there’s yet another warning that too many doctors are whipping out their prescription pads all too readily and writing scripts for retirement-age Americans, who now take on average three psychiatric drugs without any mental health history.

Research published in the JAMA Internal Medicine shows that over-prescribing of powerful psychotropic drugs, including sleeping pills, painkillers, and anti-depressants may be more common than believed. The study was based on an analysis of data from a big number of doctors’ office visits, with researchers finding the number of “polypharmacy” incidents (cases in which seniors received scripts for multiple drugs) increased between 2004 and 2013 from 1.5 million to 3.68 million.

This doubling resulted from seniors’ greater openness in talking with their doctors about mental health issues, and, in instances where visits were related to “anxiety, insomnia, or depression,” the researchers write. But, in disturbing fashion, a high number of women and rural patients were involved in cases where multiple psychotropics were prescribed, and many of the prescriptions were for painkillers.

top-selling_edited-300x163Big Pharma has ruthlessly exploited a well-intentioned measure that sought to provide medications to treat patients with rare diseases that might otherwise have been ignored. Drug companies, instead, have manipulated the 1983 Orphan Drug Act to create legally protected monopolies so they can gouge desperate patients with astronomically priced products that already were taken by as many as millions.

These findings, part of an investigation by Kaiser Health News, a nonpartisan service focused on health policy issues, were just some of the outrages that surfaced in recent days involving Big Pharma: Two big drug makers have just agreed to pay hundreds of millions in fines for anti-competitive practices or failing to report suspicious transactions, while two pharmacy operations also will fork over millions to settle suits with federal authorities over anti-kickback violations or lax controls.

Kaiser said its scrutiny of orphan drugs, those targeted at diseases affecting fewer than 200,000 Americans nationwide, found that a third of the approvals by the federal Food and Drug Administration involved medications that already were approved for mass markets and were simply re-purposed.

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