Articles Posted in Addiction

us_inequality_600px
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.

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.

vaper-300x112The Trump Administration has sent disturbing signals on whether it will keep Big Tobacco from hooking more Americans on high-tech, nicotine-addictive products—so-called e-cigarettes used, especially by the young, for “vaping,” as well as cigars and hookahs.

The federal Food and Drug Administration, almost exactly a year ago, announced it would crack down, in particular, on e-cigarettes, forcing their makers to submit them for regulatory approval and oversight. Uncle Sam also barred makers from targeting the young with certain kinds of product advertising and giveaways. E-cigarettes still cannot be sold to consumers younger than 18 and free samples are still barred.

But the Washington Post has reported that the administration is delaying key aspects of its rules on vaping, cigars, and hookahs so newly installed federal health officials can get up to speed in their posts.

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.

vaping-300x200Some young users are experimenting with different ways to vape, modifying their e-cigarettes to increase the smoke and the high—and raising more concerns about the health harms of this hot pastime.

Researchers say they found that a quarter of the 1,800 or so of the youthful vapers they studied engaged in a practice dubbed “dripping.” They altered their e-cigarettes to expose the normally sealed heating element, and then they poured flavored vaping liquids directly on it. That created a bigger puff of smoke, which, when inhaled, produced a more intense high from the blast of nicotine and other chemicals vaporized from the flavored liquids.

This practice also potentially exposes them more to addictive nicotine and cancer-causing substances, especially byproducts that result from high-heat vaporizing of the flavored liquids, the researchers reported in their study, published in the medical journal Pediatrics.

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.

oxycontin-150x150Big Pharma stayed in an unpleasant spotlight last week, with developments including:

How OxyContin reformulation may have hiked heroin-related deaths

A  new study has helped to explain the nationwide surge in heroin-related deaths, and how these likely are the unintended consequence of reformulations of OxyContin, a powerful, addictive painkiller. The study by the University of Pennsylvania and the RAND Corp., published by the National Bureau of Economic Research, scrutinized state-level data both on OxyContin abuse and heroin fatalities, which tripled from 3,000 in 2010 to 10,500 in 2014. Areas of highest misuse of the prescription painkiller dovetailed with those where heroin-related deaths spiked.

oxycontin-300x225The opioid drug abuse crisis isn’t going away with 2016’s end. If anything, even as the nation has just committed $1 billion to combating this scourge, news reports are disclosing how Big Pharma made it even worse than had been known in at least one ravaged state, and how industry players are threatening to export it so it becomes an international nightmare. Further, industry leaders may be undercutting federal law enforcement efforts crack down on its illegal aspects.

Prescription painkillers hyped in markets globally

The Los Angeles Times has landed yet another of its string of powerful investigations into Purdue, the family owned maker of OxyContin, one of the powerful painkillers at the heart of the prescription drug abuse crisis. The paper finds that Purdue responded to a tide of adverse publicity and declining sales in the United States by reorganizing its efforts into a web of related companies overseas, all under the umbrella name Mundipharma.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
Washingtonian Top Lawyer 2011
Avvo Rating 10.0 Superb Top Attorney Best Lawyers Firm
Contact Information