Articles Posted in Disclosure

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.

harlanYes, there can be progressive steps in health care—and with all the controversy and change going on in the sector it’s worth spotlighting some of these:

Patients should get access to own health records, researchers say

  • Three researchers—Dr. Harlan Krumholz of Yale Medical School (photo right), Connecticut lawyer Jennifer L. Cox, and Yale student Austin W. Jaspers—deserve credit for publishing a pointed opinion piece in the JAMA Internal Medicine detailing the costs and needless obstacles patients confront when they want copies of their own health records. As Krumholz told Reuters of the study’s message about excessive records fees charged by doctors and hospitals:  “Higher costs are a higher barrier for people to get their own information. Without that information it is not possible to correct errors in the record, get informed second opinions, donate your data to research – or share with others what is happening with your care.”  That’s spot on, doctor, as I have written recently and in my book,  The Life You Save: Nine Steps to Getting the Best Medical Care, and Avoiding the Worst. Uncle Sam has stepped in and tried to make it easier and more affordable for patients to get their own records, which Krumholz and company point out should be even more available now that they are digitized (he’s working on software to help, too). But states aren’t doing enough to help, except for Kentucky, which requires a free first copy on request, he and his colleagues say. My firm’s site contains information that may be helpful to those struggling to get their records. Here’s hoping that doctors, hospitals, and other caregiving facilities read the Jaspers, Cox, and Krumholz viewpoint, and, because it appears in one of their publications and Krumholz is a physician-researcher of growing influence, they heed it more.

skepticism-image-197x300At one point, medical experts recommended that physicians aggressively treat patients 60 and older so the top number of their blood pressure readings ran as close as possible to 140. Maybe not so, anymore. For a while, physicians were told to treat patients so their “good cholesterol” increased significantly. But maybe this approach doesn’t protect against heart disease after all. Pediatricians once warned parents to protect newborns by not exposing them to certain allergens, especially peanuts. If you haven’t had your head buried in the sand, that counsel, of course, has just changed 180 degrees.

Thanks are due to Aaron E. Carroll, a pediatrician, health research and policy expert, and columnist with the New York Times “Upshot” feature, for reminding — yet again, as repetition is the Mother of Learning — that medical news must be taken in by patient-consumers with a “dose of healthy skepticism.” This he says is especially true about reports on nutrition.

I’ve written about the harms that result from hype and the many, sometimes dramatic reverses in health and medical news. I’ve pointed out that there are accessible resources, such as the excellent healthnewsreview.org, to watchdog coverage of medical science and so-called advances. I’ve suggested that patient-consumers look closely at key elements in research stories, including how the work was done, how long the study ran, whether its data is visible and if it was published in a reputable medical journal. This will help savvy readers look askance, even at pieces in quality news sites — such as recent articles touting turmeric or eating lots of hot peppers.

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.

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?

med-records-300x200In the best of all worlds, none of us will need any time soon to race to a nearby urgent care center or to pop by the retail, walk-in clinics that have sprouted in neighborhood drug stores across the country. But if you do find yourself at one of these “doc-in-a-box” clinics, here is some good advice. A lot of this applies to regular doctor visits, too.

A tip of the hat to Dr. Peter Ubel, who posted recently at Forbes and KevinMD.com, the physician information-sharing site, his suggestions of a half dozen “essentials” that patient-consumers might need to know before a retail clinic visit. He based these on positions taken by the American College of Physicians and published in the peer reviewed  Annals of Internal Medicine.

Ubel says “doc in a box” operations (retail clinics, often staffed with physician assistants or nurses) are suitable for low-level, ordinary treatment for things like poison ivy or sore throat. When patients go to these clinics, they need later to fully inform their doctors about the care they got (see the next paragraph). They shouldn’t take referrals to specialists from staff at walk-in clinics. The facilities are OK for patients who are “relatively healthy,” and who don’t have a “complex medical history,” meaning they lack chronic or difficult conditions. Patients with greater challenges need to see their own doctors, regularly if need be. Ubel calls out his colleagues, noting that if they were more responsive to their patients, or figured out alternatives when they can’t, docs in boxes wouldn’t be flourishing as they are.

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

knee-replacement-300x240Uncle Sam is struggling to figure how best to ensure the safety, quality, and accessibility of a major surgery for a sharply rising number of seniors who need it and want the government, through Medicare, to pay for it. Baby boomers, after decades of running, dancing, aerobics, football, basketball, zoomba, and all manner of joint-stressing activity, are lining up for knee replacements. Where should these procedures occur and how should they be paid for and evaluated?

The New York Times has reported that surgeons, some in hospitals and some in free-standing surgical centers, are riven by proposed rule changes that would allow patients 65 and older with Medicare to undergo complex, extensive knee replacement operations on an outpatient basis.

The surgeons who now do these operations in hospitals say this is a risky move for patients, who now typically spend several days hospitalized in recovery. The “hospital” docs say knee replacement is a complex procedure, with high risk of infection and post-operative complications, because, for example, patients receive powerful clot-busting drugs and potent painkillers as part of the surgical regimen.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
Washingtonian Top Lawyer 2011
Avvo Rating 10.0 Superb Top Attorney Best Lawyers Firm
Contact Information