Articles Posted in Conflicts of Interest

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.

embarrass-300x172Health news readers look out: media organizations seem to be struggling with an outbreak of the whoopsies—as in, “Whoopsie, if we had more sense, we wouldn’t have put out the story you just read.”

The flare-up of embarrassing content, as chronicled well by the Healthnewsreview.org, a health information watchdog site, also seems to be a double problem for some media outlets that ironically have just warned their audiences about fake news.

As always, the dubious, low-value information concentrates on diet and nutrition topics — for instance, that small amounts of alcohol or coffee sway cancer risk or that eating chocolate makes your heart beat more regularly.

Polycythemia vera is so rare that just under 3 or so per 100,000 American men, most older than 60, are diagnosed each year with this rare form of blood cancer. Pseudobulbar affect, or PBA, is an uncommon neurological condition afflicting as few as 2 million Americans, causing them to experience uncontrolled, inappropriate bouts of laughter or tears.

What  links these two unusual maladies? Big Pharma hype: Both have taken starring roles in audacious and apparently successful advertising and marketing campaigns that have surprised even experts in the field.

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Photos:  Sen. Sheldon Whitehouse,  Sen. Patty Murray,  Rep. Chuck Fleischmann,  Rep. Chris Collins, HHS Secty. Tom Price

The U.S. Congress, based on its members’ legally required financial disclosures, fares far better than most. Senators and representatives are worth a net $1 million on average. But is it seemly for so many of our crucial voices in the nation’s capital to be enriching themselves even more, with some trading stocks in areas—like health care—in which they also are legislating?

Politico, the website devoted to politics, deserves credit for digging into 21,300 stock trades lawmakers made in the last two years. Reporters found that 384 of the nation’s 535 members of the House and Senate had zero such activity. But a handful of lawmakers accounted for hefty dealing, with Mike McCaul, a Texas House Republican, racking up more than 7,000 trades.

IMG_1029-300x201Although critics—including the agency’s incoming chief—want the federal Food and Drug Administration to speed its approval processes for prescription medications, new research shows there can be significant risks in a go-go-go approach to Big Pharma oversight. Experts at Yale Medical School have found that a third of the drugs that hit the market with FDA approval between 2001 and 2010 suffered major safety issues that were only found after the medications became publicly available.

Of 222 drugs scrutinized by researchers, 71 were withdrawn or required public announcements about their previously undiscovered risks, including some that were slapped with “black box” warnings—one of the FDA’s most stern indicators a medication carries significant side effects.

The authors of the study, published in the Journal of the American Medical Association, said the drug approval process is imperfect, and it can frustrate many because it can be time-consuming, taking years for a medication to go from lab bench to bedside.

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.

DrugNNTs-228x300Patients’ pocketbooks benefit when hospitals take simple steps to prevent Big Pharma from swaying what gets scribbled on doctors’ prescription pads: Just by curbing drug sales people’s free access to hawk their wares, teaching hospitals have found that their doctors tended to order fewer promoted brand-name drugs and instead prescribed less costly, more generic versions, research shows.

The study, published in the Journal of the American Medical Association, was based on an analysis of more than 1 million scripts by more than 2,000 MDs at 19 academic medical centers, comparing their prescribing to almost 25,000 control physicians elsewhere. Researchers looked at records on 262 drugs in eight classes in a period from 2006 and 2012.

Where teaching hospitals—under pressure from patient-consumers and pricing lawsuits—had put in place policies to rein in Big Pharma’s high pressure selling, including with meals and gifts, doctors reduced their prescribing of pricey brand-name drugs, the researchers found.

oregon-300x198For policy-makers and politicians who seek to offer robust, transparent information about the quality and safety of all too often troubled nursing homes, a newspaper investigation in Oregon underscores how poor execution guts good intentions.

The Oregonian deserves praise for discovering that a highly praised public health initiative in the Pacific Northwest foundered due to weak oversight and follow-up by regulators and others involved.

The project started with a great idea that many in health care discuss often: Taking public data about nursing homes and posting it online on a website targeted at families in desperate need for information to decide which care facilities are best for their ailing, infirm loved ones.

defib-st-judeThe serious, slowly disclosed problems of a manufacturer and its implanted heart defibrillators may offer more needed cautions to Food and Drug Administration critics who want regulators to rush the oversight of drug and medical device makers and make the agency more welcoming to big business.

St. Jude Medical, the New York Times has reported, has received a written rebuke that the FDA has hit the wall with the company and wants it to deal with its product problems. The agency says it is fed up because the company has dawdled for years in letting patients, as well as its senior management and medical advisory board know that it long has experienced major woes with its heart devices batteries.

St. Jude has been forced to issue recall notices on hundreds of thousands of its defibrillators. Hundreds of cases have been reported in which their batteries died unexpectedly. Dozens of patients have suffered “adverse effects,” and at least two deaths have been attributed to device failures.

IMG_1029-300x201At a time when drug costs are skyrocketing and Americans are demanding relief, President Trump’s nominee to be the chief regulator of Big Pharma and medical device makers says he initially must sidestep a lot of oversight of the industry because his deep ties to it might cause conflicts of interest.

Scott Gottlieb made his ethics disclosure as he gets set for congressional vetting of his appointment as head of the federal Food and Drug Administration.

Critics question if Gottlieb, a physician, is too cozy to crack down on excesses in an industry in which he has worked for most of his career and that has paid him millions of dollars. He has pledged to speed up FDA drug and medical device reviews, and to slash the agency’s bureaucracy and red tape.

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