Articles Posted in Disclosure

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Of 222 drugs scrutinized by researchers, 71 were withdrawn or required public announcements about their previously undiscovered risks, including some that were slapped with “black box” warnings—one of the FDA’s most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

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.

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.

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.

23andMetest-300x229Federal regulators have reversed themselves and approved a company’s controversial plan to sell direct to customers saliva-based tests that can predict their genetic risk for diseases like Alzheimer’s and Parkinson’s.

Officials of the federal Food and Drug Administration emphasized that the tests cannot show conclusively if individuals will develop conditions for which they may have genetic risk. They said any health test results should be discussed fully with doctors.

The FDA said it would keep close tabs on the online-order products of  23andMe, which previously had sought to market its saliva tests not only for consumers’ genealogies but also for their health interests. The FDA slapped down the firm’s first foray into health measurements:  23andMe in 2013 had charged $99 for a test that it claimed gave information, genetic and otherwise, on 240 conditions and traits. Regulators halted those tests, requiring 23andMe and others in the field  to prove their products’ accuracy and to clarify that users understood what they were paying for and any test data.

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.

cybertrollOnline trolls who have wreaked havoc on traditional news sources also are bedeviling scientific and medical publications. Although experts have benefited from much greater access to information about studies and key developments in their field, they’re also struggling to ensure the articles they get on the Internet are accurate, fair, and responsible. This  battle over the credibility of information is critical not just to academics in ivy towers. It could affect science, medicine, and the public’s health care. Some recent reports illustrate why.

Let’s start with some Polish researchers’ light-hearted way to lance, in deadly serious fashion, a nasty boil in medical-scientific publication—the viral spread of “predatory” journals. These online outlets have proliferated partly in response to an imperative in academia (including in medical-scientific research) to “publish or perish.” Rising PhDs  and even many MDs are under incredible pressure to build their credentials and institutional standing by showing they can get their studies disseminated in professional journals.

But gone are the days when these publications were scarce, based often in elite institutions, and engaged in glacial peer reviews, which often were back-scratching exercises among cadres of medical or scientific good ol’ guys, all familiar with each other dating, perhaps, from their days in prep schools.

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