Wednesday, March 25, 2009

Is there evidence for heart therapy in mainstream medicine?

Worth reading and worth drawing up a list of questions for your provider.

Note that while this article favors use of aspirin, the downside of long term ASA is an issue to question. ASA is something, even in low dose, that over time can cause the cell wall membrane of red blood cells to disintegrate. Natural therapy may include vitamin E, nattokinase, cayenne, garlic (see ALLI-C, right column), or the heart health promoting herb - hawthorne. (More information on these natural treatments may be found here.

Consider as well that there is a great deal of doubt about the veracity of "double blind studies". Most researchers do know that these studies can be manipulated quite easily to get a "desired" result.
A reader poses this query: "I'm intrigued by your comment that "...there is a great deal of doubt about the veracity of 'double blind studies.' Most researchers do know that these studies can be manipulated quite easily to get a 'desired' result.Would you please elaborate? How can these studies be manipulated to get a desired result? Can you provide some examples that are suspicious along those lines?"

The answer is Rosenthal Effect and it is displayed in the film "My Fair Lady". But then money and notoriety, along with the extreme pressure of "publish or perish" are other vectors to be considered.

The Vast Majority of Recommendations Given to Heart Patients Are NOT Supported by Good Science!

Study Questions Evidence Behind Heart Therapies
By Ron Winslow/ WSJ
FEBRUARY 24, 2009

Heart disease is among the most studied illnesses in all of medicine, yet just 11% of more than 2,700 recommendations approved by cardiologists for treating heart patients are supported by high-quality scientific testing, according to new research.

About half the medical recommendations for heart patients have limited scientific backing, according to a study published in Wednesday's Journal of the American Medical Association. Instead, they are based mostly on expert opinion -- subjective viewpoints where consensus is often lacking.

A daily aspirin for heart patients is supported by rigorous scientific research.
For instance, people who previously have had a heart attack and take an aspirin daily to help avert a second such incident can rest assured that the treatment is supported by rigorous scientific studies. But there is much less certainty around another common recommendation that patients treated with artery-opening stents remain on a potent blood thinner for a year to avoid a rare but potentially life-threatening blood clot. The downside: Patients who stay on blood thinners for an extended time risk potential complications if they need urgent surgery.

The findings from the JAMA study reflect the challenge doctors and patients face in choosing the best course of treatment for a variety of conditions. And they underscore that even though drug and device companies, government agencies and philanthropic groups have spent billions of dollars developing and testing new treatments in recent years, much of what happens in the doctor's office or the hospital operating suite might not be based on rigorous scientific evidence.

"In most situations that we encounter when we see patients, it isn't so clear what is the best thing to do," says Pierluigi Tricoci, a cardiologist at Duke University's Duke Clinical Research Institute and lead author of the study.

For more than two decades, health-policy experts, health insurers and employers have been beating the drum for evidence about what works and what doesn't in medicine in an effort to reduce wide variation in medical care, cut health-care costs and develop standards by which to measure the performance of doctors, hospitals and health plans.

This month, the Obama administration and Congress budgeted more than $1 billion of the economic stimulus package to fund research for comparing the effectiveness of different treatments in head-to-head studies aimed at providing evidence to clinicians and insurers on the best treatment strategies.

"We need those studies to make the kind of changes in health care that are being talked about -- being sure we get the best possible care for our patients in the most cost-effective manner," says Sidney Smith, a medical guidelines expert and cardiologist at University of North Carolina, Chapel Hill and senior author of the JAMA paper.

The American College of Cardiology and the American Heart Association have been jointly issuing guidelines to doctors on care of cardiovascular patients for more than 20 years. Recommendations based on multiple randomized clinical trials, in which patients are randomly assigned a treatment, are considered having the highest level of evidence. A single randomized study or non-randomized studies comprise the second level, while recommendations backed by expert opinion or case studies are considered having the weakest evidence. Guidelines are also ranked by whether empirical evidence or general opinion supports that a treatment is useful and effective or not.

For instance, strong evidence of benefit based on several randomized controlled clinical studies is behind guidelines calling for use of aspirin, cholesterol medications called statins and other pills called beta blockers among heart patients to avoid a second heart attack. Similar rigor is behind recommendations that patients who arrive at the emergency room with a major heart attack get treated with an angioplasty balloon within 90 minutes.

Experts Disagree
But such examples are the exception. For a variety of other conditions, treatment recommendations rely largely on non-randomized studies or expert opinion. For instance, it's unclear at what point patients who suffer excess bleeding during a heart procedure should get a blood transfusion, Dr. Tricoci says. And debate rages among cardiologists over two new tools for assessing a patient's long-term risk of a heart attack. When does a blood test for a marker called C-reactive protein aid in making such a prediction? How about a scan to check for calcium buildup in a patient's arteries? Mounting evidence supports each test, but more data are needed to determine how they might best be used, Dr. Tricoci says.

Harlan Krumholz, a cardiologist at Yale University School of Medicine, says doctors should disclose to patients the strength of the evidence behind the care they recommend. "Treatment decisions are often made very dogmatically even when the level of evidence isn't very strong," he says.

One reason for the lack of stronger evidence is that the large "megatrials" that have dominated cardiovascular research in the past decade were sponsored by drug and device companies. While those studies provide an important source of information, they are typically designed primarily to win approval for a treatment or to widen the market for a therapy already on the market, and not to guide treatment decisions, according to the JAMA study.

Limitations of Studies
Clinical studies also typically exclude patients with complicated illness, which can limit the ability of doctors to apply findings to many of their patients. For instance, many heart patients also suffer from kidney disease. But contrast agents typically given to patients undergoing a diagnostic X-ray called cardiac catheterization can be harmful to kidneys.

Dr. Tricoci says he and his colleagues also observed that guideline writers are picked for their expertise in the field -- but they are also often those who consult regularly with industry. Such possible conflict of interest raises the potential to introduce bias into the guidelines, undermining their credibility.

Copyright 2008 Dow Jones & Company, Inc. All Rights Reserved

Tuesday, March 24, 2009

HIV/AIDS Risk to Vets

Standards at nationwide VA facilities seem to be running at an all time low. This latest incident puts not only the lives of over 3000 veterans at risk, but perhaps the lives of their families.

What also concerns me is the lack of attention to natural treatment that is able to stop the transmission of HIV to AIDS, and other therapy outside the use of anti-retrovirals that have severe health risks of their own.
HIV Risk To 3,000 Vets From Non Disinfected Pumps At VA Hospital In Miami
24 Mar 2009

Over 3,000 veterans who had routine tests at Miami's VA Medical Center are thought to be at slight risk of infection from hepatitis or HIV because the hospital discovered that a section of tube used in water pumps for colonoscopies and other gastrointestinal procedures was only being rinsed and not disinfected.

A hospital announcement on Monday, reported in the Miami Herald and other local media, said officials have sent letters to over 2,500 veterans, and are still trying to trace another 700. 3,260 patients are thought to be at risk altogether.

John Vara, chief of staff of the Miami VA Health Care System, told the press that during an internal safety review they discovered on 4 March that a part of the equipment used in colonoscopies and other gastrointestinal procedures was not being disinfected, only rinsed. This was contrary to the manufacturer's recommendation, he said.

It was an alert from the manufacturer that caused the hospital to carry out the safety review, reported the South Florida Sun Sentinel.

Vara said that a length of tube attached to a pump that is used with a type of endoscope was not being cleaned and disinfected, although the endoscope itself (the tube containing a fiber optic camera that goes inside the patient) was.

The risk comes from infection caused by the slight chance of backflow, although the pump itself does not come into contact with the patient.

Vara said there was no evidence that any of the patients had been infected, and although the risk of infection is low, he said "any risk is unacceptable", reported the Miami Herald.

There have been other incidents recently of vets being put at risk of serious infection from incorrect hospital procedures, said the Herald.

In February about 6,400 vets at a VA center in Tennessee were told to get blood tests after equipment used in colonoscopies had not been handled properly, and another center in Augusta Georgia found that more than 1,800 vets were put at risk due to non-sterile use of ear, nose and throat instruments.

According to the South Florida Sun Sentinel, Vara said they don't know why the manufacturer's recommendations for disinfecting the tube were not followed.

A patient safety expert told the paper that the risk of exposure is likely to be very small and most patients were exposed a long time ago and are most likely out of danger.

However, another said it was still important to investigate how the error came about and make sure it doesn't happen again. You don't want to alarm people, but you need to know what went wrong and how to fix it, said Dr Anthony Silvagni, who chairs a safety group and is dean at the Nova Southeastern University health sciences division.

Democratic member for Miami of the US House of Representatives, Kendrick Meek, has written to Eric K Shinseki, Secretary of the Department of Veterans Affairs, and VA inspector general George Opfer, urging them to order an investigation, and he also wants a door to door campaign to alert all veterans who might be at risk.

In his letter to them Meek said it was "stomach-turning" that veterans have to face this situation and visit Special Care Clinics for blood tests, reported the Sentinel.

The VA have set up special care clinics in the Miami VA, the Broward County VA Clinic, the Homestead VA Clinic and the Key West VA Clinic to screen patients who may be infected.

Concerned patients may call the 24 hour Miami VA hotline on 305-575-7256 or toll free on 1-877-575-7256.

Sources: Miami Herald, South Florida Sun Sentinel.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
Article URL: http://www.medicalnewstoday.com/articles/143427.php

 
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