Articles Posted in Ethics

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Of 222 drugs scrutinized by researchers, 71 were withdrawn or required public announcements about their previously undiscovered risks, including some that were slapped with “black box” warnings—one of the FDA’s most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

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.

end-of-life-800-300x198Many hospitals and doctors rightly have campaigned to get more patients to provide information in advance about their end-of-life care choices, but doesn’t that mean that the choices when made should be respected? And if they’re not, what role do the courts have?

Paula Span, a New York Times columnist who writes on aging issues, reports that a growing number of patients and families have sued hospitals, doctors, and nurses for disregarding or overriding advance directives. There are various kinds of these legal documents. But they often become part of patients’ medical records, directing caregivers, for example, that an individual does not want extreme measures taken to resuscitate them or to sustain their lives.

This can go against deep traditions in medicine, especially for caregivers accustomed to crisis responses in difficult, exigent circumstances. They think of themselves as life changers and life savers. At the same time, patients have insisted that their rights and choices demand respect. Many physicians and hospitals have recognized and encouraged this, as has the U.S. health care system more generally, for example, via Medicare.

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.

howard-300x231It may be easy to forget. But hospitals not that long ago refused to care for black Americans. If they did so, they kept them separate and far from white patients, shunning African Americans in separate wards in “freezing attics or damp basements.” Blood transfusions were taboo. The medicine was dismal and unequal, with black patients sometimes resorting to becoming test subjects to get any kind of treatment.

The nation’s capital also contributed its own notable example of a once-thriving such spot: Freedman’s in Northwest DC, which opened in 1862 and “stood out for the medical care it offered freed slaves and became an incubator for some of the country’s brightest African American physicians.”

But that venerable haven, known now as Howard University Hospital, has fallen far, the Washington Post says. Howard’s care, still for predominantly black and now poor patients, is unequal and lagging, the paper’s investigation found:

Tom_Price_official_Transition_portrait-240x300Doctors should hold the prime role in the nation’s medical policy making, Tom Price, the orthopedist who is the Trump Administration’s top health expert, has insisted. But will the U.S. Health and Human Services Secretary heed top experts in his field, writing in some of medicine’s leading journals, that he and GOP partisans lack real evidence for their assault on patients’ rights to seek legal redress when injured by medical care?

Experts from the Stanford University’s medical and law schools have just written in The New England Journal of Medicine that “this an odd time for [Price and] Congress to be considering malpractice reform.” Why? As they noted:

Malpractice environments are currently stable: the incidence of paid claims has shrunk by half in the past decade, indemnity-payment levels have declined or plateaued, and many physicians pay less for liability insurance than they did a decade ago. Price has claimed that defensive medicine is responsible for a quarter of U.S. health care spending — about $650 billion — but the best estimates are closer to $50 billion. So is a push for liability reform at this moment inappropriate? We don’t think so.”

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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