Articles Posted in Medications

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.

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.

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.

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.

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.

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.

D-vitaminsThe health care pendulum appears to have taken a bad swing to the extreme with vitamin D.  Too many Americans may be taking unnecessary tests to see if they’re deficient of this important nutrient. Too many of us are taking unneeded amounts of it.

Federal experts report that blood tests for vitamin D among Medicare beneficiaries, most 65 and older, increased 83-fold from 2000 to 2010. Testing rates rose 2.5-fold from 2009 to 2014 among those with commercial insurance.  Among a recent sample of 800,000 patients in Maine, nearly one in five had at least one test for blood levels of the vitamin over a three-year period. More than a third got two or more tests, often for vague complaints like malaise or fatigue. Labs and doctors are telling patients who have undergone tests and who have readings in the normal range of 20 to 30 nanograms of the vitamin per milliliter of blood that they suffer a deficiency.

This all is leading to what some experts are terming a “pandemic” of over-testing, faulty diagnosis, and excess consumption of a nutrient, based on sparse evidence and misplaced belief that, as the New York Times reports, “vitamin D can help turn back depression, fatigue, and muscle weakness, even heart disease or cancer. In fact, there has never been widely accepted evidence that vitamin D is helpful in preventing or treating any of those conditions.”

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.

Maryland_State_House_from_College_Ave-300x254Big Pharma’s skyrocketing prices are finally in for some real scrutiny by the U.S. Government Accountability Office (GAO), as well as new initiatives in the Maryland and New York statehouses.

The GAO—the independent, nonpartisan agency that works for Congress and often is called the “congressional watchdog”—has announced that it soon will undertake an investigation requested by three members of Congress of abuses of the federal Food and Drug Administration’s Orphan Drug Act.

That act is supposed to spur Big Pharma to develop drugs for “orphan diseases,” illnesses that affect fewer than 200,000 Americans. Drug makers have resisted investing time and money on therapies for these diseases because the medications may offer insufficient financial returns. So, Congress granted tax incentives and limited exclusive rights to makers of drugs targeted at patients with niche diseases.

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