Showing posts with label medical errors. Show all posts
Showing posts with label medical errors. Show all posts

Saturday, December 4, 2010

Saving Lives and Saving Money

The following is a quote excerpted from a Public Citizen report that looked at the US health crisis.  As we move to the unfolding of health insurance reform in 2011 it is well worth everyone's attention to the issues addressed in this post.
"...the country is in a patient safety crisis, and that medical professionals, lawmakers and regulators must do significantly more to avert it.
The 1999 landmark report, “To Err is Human,” dropped the first bombshell, reporting that between 44,000 and 98,000 Americans die in hospitals each year from medical mistakes, costing an estimated $17 billion to $29 billion annually. HHS’ new finding that medical mistakes kill 15,000 Medicare patients a month equates to 180,000 Medicare deaths per year - more than the IOM’s estimate, which attempted to cover all patients in the United States. That means that the annual death toll in this country caused by mistakes in hospitals is well over 250,000 deaths a year! But perhaps the most startling finding by HHS is that a significant number of patients suffered injuries or died needlessly, as 44 percent of the medical errors were preventable."
One of my clients recently saw the writing on the wall when he went for his regular lab work, as he is an organ transplant recipient. transplant.  The lab removed many of the tests on his doctor's order, and he will not be able to get them routinely because of program changes.

As this moves further along we see that the "advance care planning" portion is in a rule from US Department of
Health & Human Services, Centers for Medicare & Medicaid (CMS) here:
http://www.ofr.gov/OFRUpload/OFRData/2010-27969_PI.pdf
[NOTE: link went inactive following 11/29. As of 12/1 the document is available at http://tinyurl.com/3akk88e

SOURCE: Just when you thought the American people had dodged the death panel bullet (Section 1233 of the House bill), think again. Last Monday, November 29, 2010, /The Federal Register/ (page 73406) published a new funding rule for "voluntary" advance care planning consultations that changes US Department of Health and Human Services regulation pertaining to Medicare and Medicaid patients.

The new regulation states that advanced care planning consultations will now be offered (and funded) as part of the initial wellness visit for medicare patients and during all subsequent annual visits.

The Federal Register provides a uniform system for making available to the public regulations and legal notices issued by Federal agencies. Agency proclamations having general and legal effect are required to be published by act of Congress.

Has there been any media attention to this important change in health care coverage for all those receiving medicare and medicaid services" You will recall the uproar about death panels, but this week funding for these consultation sessions became part of general government regulations without fanfare.

Ione Whitlock is Chief of Research at LifeTree. On our current homepage she discusses these new Federal Regulations. Also posted there is her new essay titled "Heads up: Section 1233 again."

Ione discusses Congressman Earl Blumenauer's bill -- HR 5795 -- which was introduced this summer after passage of the health care bill, and two matching bills which were introduced in 2009 by Senator Rockefeller and Congressman Blumenauer. All these bills seek grants for programs to expand or enhance existing state programs for orders regarding life sustaining treatment (POLST).

One of the main goals of this legislation is to fully implement the POLST form into our health care system. POLST stands for Physician's Orders for Life Sustaining Treatement. It comes in many flavors including MOST, MOLST, POST and TPOPP, depending on the location.

Government funds will be used to educate "providers" who will work with the patients, their families and surrogates in filling out the POLST forms. They will learn the so-called "best practices" for discussing end-of-life care with dying patients and their loved ones. These funds will ensure that the POLST forms are recorded electronically.

Note: For more information on the history and implications of POLST, see "POLST: 'Self-Determination' or Imposed Death" http://www.lifetree.org/resources/polstInfo.html in LifeTree's Resources section.

New CMS Rule Establishes "Voluntary" End-of-Life Consultations

Americans weary of "voluntary" TSA pat-downs and full-body scans will be delighted to learn that "voluntary" end-of-life consultations are in their future as well.

The US Department of Health and Human Services, Centers for Medicare & Medicaid Services (CMS) has made it official: The "advance care planning" funding that would incentivize "voluntary" end-of-life counseling will be included in Obamacare. This funding was part of what was in the controversial "Section 1233" earlier this year. See more
extensive discussion in our alert below, posted last week.

The new CMS rule as printed in the Federal Register (Vol. 75, No. 228, Book 1) online at http://tinyurl.com/2wn5vz4
Discussion on "voluntary advance care planning" begins on page 73406.

posted 12/1/10 by IW
------------------------------------------------------------------------
Heads up: Section 1233 again.

Last March Nancy Pelosi told the American people that she and her colleagues "have to pass the bill so you can find out what's in it." Americans had already seen one part of the proposed healthcare legislation, and didn't like what they saw: The infamous Section 1233 of HR 3200 would have federalized "voluntary" end-of-life "consultations."
The section was eventually dropped.

It appears that Section 1233 is still alive and kicking.

The "advance care planning" portion is in a rule from US Department of Health & Human Services, Centers for Medicare & Medicaid (CMS) here: http://www.ofr.gov/OFRUpload/OFRData/2010-27969_PI.pdf
[NOTE: link went inactive following 11/29. As of 12/1 the document is available at http://tinyurl.com/3akk88e

The POLST part is included in pending legislation, HR 5795 "Personalize Your Care Act of 2010." See
http://tinyurl.com/24u5q37
which is a link to all the information about this bill and the actual text as a pdf at http://tinyurl.com/2a9rudq.

CMS posted the preliminary rules on Election Day; formal rules are to be published in the Federal Register on November 29. The rules include a discussion of the definition of "voluntary," although some of the more nuanced meanings of "voluntary" may have been missed (just ask any recipient of a "voluntary" TSA pat-down). The rule also includes a discussion of signature requirements for "orders" versus "requisitions" in context of diagnostic tests. The American Bar Association's Charles Sabatino, who supported Section 1233, calls the new rules "a big step forward."

Congressman Earl Blumenauer (D-OR) introduced HR 5795 this past July. It is a revised version of the legislation that he and Senator Rockefeller (D-WV) introduced last year. Blumenauer introduced HR 2911, and Rockefeller introduced S. 1150 in 2009, both titled "Advance Planning and Compassionate Care Act of 2009". Both bills included:
    * Section 211 (Advance Care Planning) was almost identical to Section 1233 of HR. 3200 " the section that was dropped from the  final bill signed in March.
    * Section 112, which would have provided funding to expand POLST.

It is Section 112 of the Rockefeller and Blumenauer bills (S 1150 and HR 2911) that is now Section 3 of HR 5795. Portability of advance directives and standards for electronic health records are also addressed in HR 5795.

Blumenauer is the congressman most often associated with POLST He is, incidentally, an advocate of legalized assisted suicide, and Rockefeller has spent decades trying to push through legislation on behalf of the organizations that evolved from the Euthanasia Society of America.

Shortly before the election, Blumenauer told a radical pro-assisted suicide group that he had reintroduced what had been known as the "death panel" legislation. He complained that Section 1233 had been dropped due to "organized opposition" from "all of the Sarah-Palin-Fox-News-tin-foil-hat" people, but "it's not stopping us from moving forward." Over the summer he had reintroduced the bill with a new name: the "Personalize Your Care Act of 2010" (HR 5795).

"Personalize" leaves the impression that this bill might put medical treatment decisions back in the hands of the individual, keeping the discussion between patient and physician. It implies that the patient might as easily "choose life" as to forgo treatment. This is pretty slick marketing, considering it is coming from the same Oregon liberals
who pushed not only assisted suicide, but rationing for "equitable distribution of resources" for "the common good." The bioethicists at Oregon Health & Science University (OHSU) who devised the "citizen parliaments" that gave Oregon its rationing scheme are some of the same bioethicists who put the fine tuning on POLST.

Blumenauer, in his remarks to the Oregon activists, went on to say that Oregon leads the way in health reform. Well, yes. Oregon health care is infamous for two things: assisted suicide, and rationing. Blumenauer's bill would impose both on the whole country.

Note: For more information on the history and implications of POLST, see "POLST: 'Self-Determination' or Imposed Death"  www.lifetree.org/resources/polstInfo.html in LifeTree's Resources section.
posted 11/24/10 by IW, revised 12/2/10 by IW

The Six Parts of the Deficit Commission's Plan for Medicare Reform Through 2020
Part #1— Reform the Medicare Sustainable Growth Rate ($26 Billion Savings)
Freezing physician pay reductions through 2013 and a one percent cut in 2014. Additionally it recommends developing a new pay formula based on care coordination and quality instead of quantity of services.
Part #2— Reform or Repeal the CLASS Act ($76 Billion Cost)
The attempt as part of the health care overhaul to address the need for residential long-term care through a voluntary insurance program is criticized as financially unsustainable under its current format.
The recommendation is for complete overhaul or repeal (the preferred option) even with a price to be paid. This is because the collection of premiums over the first five years would have provided positive cash flow.
Part #3— Medicare and Other Health Care Revisions for 2012-2020 ($316 Billion Savings)
The commission proposes the following:
  • $9 billion in waste, fraud and abuse will be saved by increasing the authority and resources of the Centers for Medicare & Medicaid Services (CMS).
  • $110 billion by introducing a simple annual deductible of $550 for Part A and Part B and 20 percent Medicare co-pays, with a cap of $7,500.
  • $38 billion through Medigap supplemental insurance reform. Eliminating coverage for the first $500 and restricting coverage to 50 percent of the next $5,000 in cost sharing. As a stretch into dangerous political territory the commission recommends the same treatment for Tricare (military version of Medicare) and federal retirees.
  • $49 billion from treating Medicaid drug rebates in the same way as Medicare for those eligible for both programs.
  • $60 billion by reducing excess payments to teaching hospitals to 120 percent of the national average salary for residents.
  • $23 billion from ceasing payment for unpaid Medicare deductibles and co-pays.
  • $9 billion by bringing forward, by two years, plans to change reimbursements for home health providers.
  • $18 billion by introducing a change in the Federal Employee Health Benefit program and providing a fixed subsidy. The commission also recommends evaluation of the program to determine, based on the experience with FEHB reform, whether a voucher system could work for Medicare.
Part #4— Aggressive Implementation and Expansion of Payment Reform Pilots
The commission sees opportunities to expand programs aggressively where there is evidence of cost control, without need for additional Congressional approval. Note that this expansion will not be at the cost of providing quality care.
Part #5— Eliminate Provider Carve-Outs from IPAB
This recommendation allows the Independent Payment Advisory Board (IPAB) to include provider groups, such as hospitals, within its authority to recommend changes in revised payment policies.
Part #6— Establish a Long-Term Global Budget for Total Health Care Spending
This requires establishing a total federal health care budget and limiting growth to GDP plus 1 percent with a process to review spending. It additionally requires structural reforms if the spending exceeds the targets. The commission also said that if spending continues to grow, tax benefits for employer provided health insurance should be eliminated.

Friday, January 15, 2010

Mixups Sidetrack Cancer Research

More than 100 studies utilizing cancer cells were completed using the wrong cells for the focus of the study. This may contribute to the real problem surrounding perpetuating research but never finding cancer cures.

The majority of people invloved in "races for the cures" rally have no idea where the money goes.  I think it is past time for people to demand results, not just sit passively by and think that fundraising and research organizations will meet this long over due goal.

It is also time for Big PhRMA stops pushing dangerous, unproven and ineffective drugs on mainstream medicine and often desperate patients, knowing full well their products have major problesm.

By John Gever, Senior Editor, MedPage Today
January 14, 2010

Explain to interested patients that medical research often begins with "test tube" studies of isolated cells and tissues. If they are mislabeled or contaminated, the results may send researchers off in the wrong direction and the error may not be detected until other studies are performed.

Review: Three cell lines thought to be esophageal cancer cells actually came from other tumor types, potentially misdirecting clinical trials and other studies, researchers said.

Genetic profiling revealed that the cell lines SEG-1, BIC-1, and SK-GT-5 -- believed to be esophageal adenocarcinoma cells -- were really derived from lung carcinoma, colorectal adenocarcinoma, and gastric fundus carcinoma, according to Winand N.M. Dinjens, PhD, of Erasmus University in Rotterdam, Netherlands, and colleagues.

"We have identified more than 100 scientific publications in which the contaminated cell lines . . . were used," they reported online in the Journal of the National Cancer Institute.

They pointed out that at least three ongoing research projects sponsored by the National Institutes of Health were funded on the basis of these cell lines.

Dinjens and colleagues also found two ongoing clinical trials that were based on experimental results obtained with the misidentified lines -- one testing sorafenib (Nexavar), the other evaluating an investigational telomerase inhibitor.

The authors recommended that both trials be reconsidered, as the underlying rationale is now suspect, but an editorial accompanying the report suggested that stopping the trials may not be warranted.

A total of 14 esophageal adenocarcinoma cell lines are currently in use, according to Dinjens and colleagues, and these are the foundation for nearly all experimental science in the disease, in the absence of animal models and familial cases.

It is generally recognized that many cell lines have been contaminated or mislabeled, they said.

Because the original tissues from which 13 of the 14 esophageal cancer cell lines were derived remain available, the researchers set out to authenticate the lines.

They used short tandem repeat profiling to compare genotypes of the cell lines with cells from the original tissues, supplemented by analyzing the exons and the intron-exon boundaries for the TP53 gene.

The TP53 gene is stable enough that mutations should persist through many cell divisions, and should therefore match in the cell lines and original tissues.

Dinjens and colleagues found that 10 of the 13 lines they analyzed were close genetic matches for the original tissues, despite "hundreds, perhaps thousands, of culture passages."

But for SEG-1, BIC-1, and SK-GT-5, the findings showed clear differences. Their genotypes were better matches for other tumor types.

The authors indicated that the scientist who originally derived SEG-1 and BIC-1 confirmed their results for those lines.

"Clearly, contamination occurred early during establishment of the cell lines, and all of the cultures that were distributed subsequently to different laboratories were contaminated," Dinjens and colleagues wrote.
SG-GT-5 turned out to be identical to a gastric fundus tumor line known as SG-GT-2. As with the other lines, communication with the researcher who first developed SG-GT-5 established that it must have been contaminated either at the site of origin or during early exchanges of cells with other laboratories.

"This report is a call for all scientists to authenticate their cell lines," Dinjens and colleagues concluded.

In an accompanying editorial, Robert H. Shoemaker, PhD, of the National Cancer Institute, agreed that the findings were important, but he disputed the suggestion that the two clinical trials are irretrievably compromised.

In both cases, Shoemaker indicated, there are other rationales for the therapies besides the in vitro results obtained with the disgraced cell lines.

Shoemaker also noted that the phenomenon of contaminated or mislabeled cell lines is not new.

The current study's most important impact, he wrote, "will likely be the definition of 10 esophageal adenocarcinoma tumor cell lines of proven authenticity for use in studies addressing this disease."

The study was funded from internal university sources.

No potential conflicts of interest were reported by study authors or the editorialist.

Primary source: Journal of the National Cancer Institute
Source reference: Boonstra J, et al "Verification and unmasking of widely used human esophageal adenocarcinoma cell lines" J Natl Cancer Inst 2010; DOI: 10.1093/jnci/djp499.

Additional source: Journal of the National Cancer Institute
Source reference: Shoemaker R, "Identification of Bona Fide Esophageal Adenocarcinoma Cell Lines" J Natl Cancer Inst2010; DOI: 10.1093/jnci/djp526.
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Friday, May 22, 2009

Today's Drug Promoting Insanity

As I've been saying lately, what we have in the US is medical care, not health care. And the medical care we have ranks very low in comparison to many other countries.

There are many reasons for this poor state of affairs, and here are a few reasons why things are as they are -
1. Older people should take anti hypertensive drugs even if they do not have hypertension.

This idea seems to be the brainchild of some medical researchers in the UK. They believe a "polypill" made up of the standard drugs used currently as the cookie cutter treatment for blood pressure will prevent heart disease and stroke.

My choice would be vitamin E and magnesium, plus a more customized individual plan for anyone concerned about these issues.

2. The anti-cholesterol drug fenofibrate (Tricor or Triglide)appears to reduce risks of amputation for diabetics by as much as 36 percent, a study has found. This drug runs about $75 for 90 pills. And it has some great side effects I know everyone wants to experience, especially when hit with their impact by surprise because the prescriber overlooked explaining them, as required by law.

The study was published in a special edition on diabetes by The Lancet, which included another study on how rigorous monitoring and control of blood sugar reduces heart attacks.

Well, just for starters, how is amputation directly related to controlling blood sugar and reducing heart attacks?

Perhaps these medical whiz kids need to go back to the drawing board to read the research that says anti-cholesterol drugs do not reduce risk of heart attack, and they don't really do much for LDL or blood sugar lowering either.

However, if a person with diabetes takes adequate amounts of vitamin E daily, they will find that they can prevent neuropathy and the reduce the risk of losing toes, feet, or limbs.

And because vitamin E is an oxygenator it can act to lower blood pressure as doing is increased over time.

A little Alli-C thrown in the mix easily increases the benefits, and garlic has some blood sugar lowering effect as well.

Then there is Kufner's Powder, heavily laden with B vitamins and trace minerals, shown in the very first hospital based study to reverse gangrene in a limb of an older man with diabetes. And consider enzymes, especially lipase, it might be beneficial.

Seems to be another indication we need more open minds and more creative thinking in medicine now days...

3. "A study by Cancer Research UK found that pancreatic cancer can spread quickly to a tumor, despite a healthy blood supply, and gave evidence why conventional cancer treatments such as Eli Lilly and Co's Gemzar were often ineffective.

The study found that combining cancer treatment Gemzar with Infinity Pharmaceutical's experimental drug IPI-926 made the treatment work better in mice with pancreatic cancer."

Yes, the treatment works better in mice!

And the statistics are not good: "Pancreatic cancer is diagnosed in 230,000 people across the world each year, with 7,600 new cases in Britain and 37,000 new cases in the United States, according to Cancer Research UK."

So what might you do?

Well, there is a natural treatment that has been proven in an FDA funded study that seems to get up to an 83% cure rate.

It has lots of vitamins and enzymes, plus a different nutritional approach.

And after you've looked over just these three items consider that in 1999, the Institute of Medicine (IOM) issued an alarming report titled "To Err is Human," detailing the toll of preventable medical errors in the U.S; it estimated that up to 98,000 Americans die annually from them.

Comments on this study show that now a decade later as more than 100,000 people are dying from the same cause, as the CDC reports, why aren't the "right" questions being asked.

Are we really hoping for reform in medical care?

 
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