Articles Posted in Medications

http://www.protectpatientsblog.com/wp-content/uploads/sites/69/2016/09/Food_and_Drug_Administration_logo.svg_-300x129.pngTo hear some powerful proponents tell it, Uncle Sam needs to really hurry up the government’s approval of drugs and medical devices. He’s got to make oversight over them easier, lighter, and less complex.

But consider just some of the health news in recent days:

marijuana-smoking-131013-300x200Although marijuana is marching toward legalization across the United States, expectant moms may wish to think long and hard still about smoking or ingesting a substance that has become as ubiquitous in some households as aspirin or a bottle of chardonnay. The New York Times has delved into this discussion, even as other news outlets recently have provided parental warnings about hype over apps for baby care and tossing some toxic homeopathic teething remedies.

Pot? Not for expectant moms

Let’s turn first, and not be blue noses about it, to why moms would consider pot while pregnant. Data show that few do (an estimated 4 percent of more than 200,000 women in one 12-year sample — though the number had doubled in recent time). For younger women, the answer may be, just because. They don’t equate it with risk but with recreation. They say they try to be cautious with it, just as they might curtail their alcohol consumption but still have a rare drink. Older and expectant moms may use pot, as many women do, because they find it helps with depression, anxiety, stress, pain, nausea and vomiting.

10650-insulin-diabetes-300x169Just under a century ago, a team of Canadian scientists made the breakthrough that led to widely available insulin as an effective treatment for diabetes, which then was a deadly disease. The researchers, who won the Nobel Prize, also made a jaw-dropping gesture to ensure their discovery would benefit the afflicted: They handed over their lucrative patent on insulin to the University of Toronto to ensure the fearsome illness would be conquered.

The university, alas, turned quickly to commercial drug makers, licensing them to produce the life-saving medication. And flash forward to now, and, after years of rising anger, a group of diabetes patients has sued three drug makers, asserting they systematically and fraudulently price-gouged them for their must-have treatment.

Insulin has become a $24 billion global market, with myriad profit-grabbing hands of distributors and supposed cost-controllers moving it from makers to patients, each middleman taking his piece. Patients say they’re aggravated that the various Big Pharma players appear to work in concert to send insulin’s price, in lockstep, skyrocketing. One vendor’s product carried a sticker price of $21 per vial two decades ago. It now costs $255 for the same amount.

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.

pthiel-200x300Although attention has focused on the GOP-promised repeal and replacement of the Affordable Care Act, other big changes also are afoot in the federal government that will have significant effects on health care in this country.

There are appointments pending from President Trump at the federal Food and Drug Administration and the Centers for Disease Control and Prevention. Sonny Perdue, the administration’s pick for Agriculture secretary, also will play a big public health role, as will the personnel decisions that may be made at the troubled National Institutes of Health, where, for now, Francis Collins will continue to lead.

Will the FDA be run by a venture capitalist?

Female_black_symbol-200x300Modern medicine isn’t addressing women’s distinctive health care needs as optimally as needed, with research further showing it may be time to dial down expectations about breast cancer screening, while heightening physicians’ awareness and best practices in eliminating gender biases.

Women also may want to keep close tabs on how changes with the Affordable Care Act affect them, and they may be well-served to remind themselves about Texas’ sudden surge in maternal deaths and one of health care’s major, gender-based debacles in hormone treatments for females.

Over-treatment tied to mammograms

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.

price-portrait-300x253The Republican-controlled Senate has launched itself in a late-night session on the path to its long-pledged repeal and replacement of the Affordable Care Act, aka Obamacare. The GOP-controlled House on  Friday the 13th followed close behind.

Lawmakers have chosen a complex parliamentary path. GOP members are expressing confusion about their way forward, even as doubts are being voiced by GOP governors in states where the ACA has expanded health care for the poor through Medicaid. The president-elect has called for swift action — insisting on not just Obamacare’s repeal but also its replacement with an undefined plan that he says will provide health care coverage that’s better than what exists now and for more Americans.

With big, many, and byzantine legislative steps needing to be taken even beyond “repeal,” can the ACA be replaced, too — and with what?

Cattle-300x219What happens on farms in Georgia and Oregon or ranches in Texas and Wyoming has a direct and significant effect on how healthy hospitalized patients stay in Buffalo, Baltimore, or Los Angeles. And now federal regulators have put in full effect a big change to help protect humans’ well-being by ensuring medically important antibiotics don’t get squandered in agriculture, where they’re used mainly to make livestock bigger and more profitable for farmers and ranchers.

Under new federal Food and Drug Administration regulations, antibiotics that are used to treat people and their diseases cannot be fed to animals principally to promote their growth. Before such drugs can be added to feed, a veterinarian now must approve and supervise their use—a new step that will make them more expensive and inconvenient.

Animal consumption of antibiotics has soared in recent years. Even with growing pressure from public health officials concerned that the medications’ germ-fighting capacities are diminishing due to over-use, American farmers and ranchers increased their antibiotic purchases by 2 percent in 2015 versus the year previous, federal data show. Growers pumped 9.7 million kilograms of the valuable bug-fighting drugs into cattle, pigs, and chickens destined for American kitchens and dining tables.

peanutsAlthough many of us would like nothing better than to dote on a favorite baby all day long, medical experts have offered some surprising turnarounds and concessions for the new year about what they do and don’t know about infant care-giving.

They have made a 180-degree reversal on their advice to parents on dealing with the rising problem of peanut allergies, while also suggesting that a familiar product may be more useful than thought to combat a common skin woe. And they have said that 90 percent of the medications given to newborns aren’t approved for such uses by the federal Food and Drug Administration.

Feed the baby peanuts, docs now say

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