October 21, 2014

New Alzheimer’s Imaging Test Provides NO Benefits, Only Profits for Drug Companies

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Worthless CT Scan for Alzheimer's

by Vera Sharav
Alliance for Human Research Protection

 On Friday, April 6, the FDA approved another of Eli Lilly’s “breakthroughs” whose clinical value is questionable (at best).  The focus, in this instance, is not a therapeutic intervention, but rather a test using a radioactive imaging agent– a dye, brand name, Amyvid (florbetapir)–which is to be used in brain PET scans to identify amyloid clumps. The presence of amyloid in the brains of Alzheimer’s patients has been observed post mortem in autopsies. However, amyloid plaques have also been found in the brains of at least 20% of healthy elder adults with no cognitive problems.  Thus, the finding of amyloids doesn’t mean the person has Alzheimer’s.

Furthermore, FDA acknowledges that most doctors are not trained to interpret brain scan results–raising further doubts about the justification for its marketing approval of Amyvid.  The test will likely result in a high percentage of false-positives greatly expanding the number of people mistakenly identified as having Alzheimer’s.   Such a flawed test is of no clinical value–it will increase anxiety, add confusion for seniors and their families, and it will increase healthcare costs without any benefit for patients with Alzheimer’s.

As a thoughtful comment on Forbes website points out, “(sadly) amyloid imaging does nothing to contribute in any substantive way to a change in standard or attempted management of dementia.”

The dye was developed at the University of Pennsylvania which reaped a hefty profit when Eli Lilly bought it for $800 million. News of FDA’s approval–a move, which Forbes reported, “took most people who watch pharmaceutical companies by surprise”– was accompanied by flim flam hypein an effort to overcome its negative aspects by claiming those aspects to be positives.:  “We’re excited. The approval means that this product will finally be available to the patients who need, and can benefit from, this,” said Avid Radiopharmaceuticals’ founder and chief executive officer, Daniel Skovronsky, 39, a Penn neuropathologist.

In point of fact, Lilly nadmits in the drug’s label that:  “A positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder.”
To overcome the lack of professional competence to read PET scans, the FDA worked with Eli Lilly to develop a three-hour online crash training program for doctors!!
However, the professional incompetence problem is hardly resolved.

Forbes reports that Lilly’s Amyvid prescribing label discloses that in a 59-patient study in which ALL Amyvid readers of a patient’s Alzheimer’s status–that was later determined by autopsy–got at least 5% and up to 14% of diagnoses wrong. This inconsistency indicates that the test is inaccurate, not objective, is dependent on subjective interpretation.

Though it lacks a clinical justification for its use, Amyvid has a commercial use for drug developers.
Shirley Wang of The Wall Street Journal notes that those who favor using Amyvid and similar agents currently under development have said that such technology will accelerate research by helping to identify people at high risk of developing Alzheimer’s and to enroll such people in clinical drug trials. Matthew Herper of Forbes states: “Where tests like Amyvid will obviously be very useful is in testing new drugs. If drug companies can screen out patients who are likely not to have Alzheimer’s, they are far more likely to be able to show that medicines aimed at Alzheimer’s are effective in clinical trials…. This really is a clever move by Lilly to make some profit on a research tool. ”

What an ingenious utilitarian use for a flawed, inaccurate screening test! Eli Lilly will be marketing a test–with FDA’s seal of approval–that will stigmatize and traumatize hundreds of thousands of elder people who will then be corralled to serve as free human drug testing subjects!

Eli Lilly has been enormously successful in marketing clinically useless drugs with debilitating side-effects that became blockbuster sellers, thanks to aggressive, unethical marketing tactics –Oraflex, Evista, Prozac, Zyprexa, Xigris, to name a few.

In 2001, having gained FDA approval of  Xigris for the treatment of sepsis, which it sold for $6,800, then raised to $8,000 per 4-day course of treatment,
Eli Lilly’s chairman, president and CEO, Sidney Taurel, told shareholders: “No medicine better symbolizes our mission than Xigris,” calling it “one of our industry’s genuine breakthroughs.”

But Xigris was found to be worthless for the treatment of sepsis shock–it failed to show a survival benefit.  To promote the use of Xigris, Lilly embarked on a deceptive marketing campaign to overcome negative evidence–i.e. increased bleeding and deaths in clinical trials.  Lilly’s aggressive marketing blitz included manipulating–with cash payments–a task force of 20 scientists and hospital directors charged with formulating sepsis clinical guidelines. The guidelines recommended Xigris despite negative evidence from clinical trials.  The company ultimately withdrew Xigris in 2011 after cashing in about $1 Billion.

If the FDA’s goal in its licensing determinations is to bankrupt the nation’s healthcare budget by approving worthless, all-too-often hazardous drugs, vaccines, and drug devices that undermine rather than improve health, it is doing a commendable job!

Read the Full Article Here: http://www.ahrp.org/cms/content/view/842/9/

See Also:

Coconut Oil and Alzheimer’s Disease: The News is Spreading

 

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Virgin Coconut Oil Beats Drugs in Treating Alzheimer’s

A Holistic Guide to Geriatric Care – eBook

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In this book we look at the problems and causes of Alzheimer’s as they are related to an epidemic of prescription drugs being marketed to seniors, and we look at the strong evidence for dietary intervention, starting with coconut oil.

We bring you the stories of 10 different families who saw Alzheimer’s lessened or reversed by adding coconut oil to their diet, which is representative of thousands of others who are experiencing similar results. We offer guidelines on usage and types of coconut oil to consider, as well as other non-drug tips for holistic geriatric care.

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Boston Nurses Speak Out Against Mandatory Flu Shots

Boston Nurses Speak Out Against Mandatory Flu Shots

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Last month (September 2014) the Massachusetts Nurses Association sued Brigham and Women’s Hospital over a new policy that required nurses to receive the annual flu vaccine as a condition for employment.

The nurses were, of course, criticized by the medical establishment. They were accused of putting their own interests above the needs of patients. Lynn Nicholas, president of the Massachusetts Hospital Association, stated that the nurses were: “putting a pet peeve of theirs above the safety and well-being of the patients they serve, their families, visitors to the hospital, and their colleagues.”

Pet peeve? Really?

When nurses all across the United States and Canada are willing to sacrifice their jobs and careers to avoid the annual flu shot, it is time to sit up and take notice. This is obviously something much more than a “pet peeve.”

Trish Powers, representing Brigham nurses in Boston fired back a comment that The Boston Globe published. It is titled “Brigham nurses know flu vaccine can do harm.”

Gardasil: The Day Our Daughter’s Life Changed

Gardasil: The Day Our Daughter’s Life Changed

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The Gardasil vaccine has changed Skylee’s life in so many ways and we do not know how many more symptoms will show up and change her life even more than it has already done. Our whole family has been affected by this vaccine and all of our lives have been turned upside down that terrible day in 2013.

If only the doctors would recognize Skylee has gone from being a healthy young girl to an invalid when the only major change in her life occurred on the day she had that single shot of Gardasil.

Will There Be An Ebola Outbreak in America?

Will There Be An Ebola Outbreak in America?

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So here is what inquiring minds want to know:

Why did U.S. health officials in Atlanta and on the ground in Africa ignore the exploding Ebola epidemic last spring?

Why did U.S. government officials fly American aid workers infected with Ebola to the U.S. rather than treating them with experimental drugs at hospitals in Africa?

Why did the U.S. government press the United Nations to adopt a resolution calling for no restrictions on international travel from Liberia and other Ebola-stricken countries?

Why did the Centers for Disease Control, supposedly the world’s leading infection control agency, fail to immediately assist Texas health officials when the first case of Ebola was diagnosed on US soil to guarantee that, at a minimum, the kind of infection control measures used in most nursing homes in America would be carried out?

Why has the Director of the CDC repeatedly stated that the only way a person can transmit Ebola is if they have a fever and said that people cannot get Ebola unless they have direct contact with the body fluids of an infected person – but that under no circumstances is Ebola airborne – when he knows, or should know, those statements could be false?

And why are experimental Ebola vaccines being fast tracked into human trials and promoted as the final solution rather than ramping up testing and production of the experimental ZMapp drug that has already saved the lives of several Ebola infected Americans?

A logical conclusion is that some people in industry, government and the World Health Organization did not want the Ebola outbreak to be confined to several nations in Africa because that would fail to create a lucrative global market for mandated use of fast tracked Ebola vaccines by every one of the seven billion human beings living on this planet.

Similarities Between 1976 Swine Flu Hoax and Ebola?

Similarities Between 1976 Swine Flu Hoax and Ebola?

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Read this before you consider purchasing a hazmat suit to protect yourself from Ebola!

Are we facing an Ebola pandemic that will kill millions, or is this just a marketing plan of the pharmaceutical industry to sell more drugs and vaccines? Is the current strain of the Ebola virus a secret creation of pharmaceutical company scientists, biological warfare researchers, or the fruit of Monsanto’s product development team?

Was Ebola created, or did it just accidentally spill over into humans from an animal host such as African fruit bats?

Is the US government intentionally not taking strong action to prevent Ebola from spreading or is there really minimal risk to Americans? Are there groups that want to decrease the world population through spreading contagious diseases such as Ebola, or is this just another imaginary plan that is being reported by certain conspiracy theory groups?

Is the Ebola virus a local epidemic, a global pandemic, or a hoax? Is life in America as we have known it about to collapse into chaos and martial law, or will we be safe and secure once we take the Ebola vaccine?

Will more people die from the Ebola vaccine than would have died from the disease itself?

All these questions have been circulating through the media over the last few months. The situation with Ebola is certainly a complex muddle of contradictory facts, opposing interpretations, and political intrigue. It reminds me very much of the 1976 Swine flu hoax — commonly called the swine flu fiasco or the swine flu debacle. More:

6 Reasons I Won’t Give My Kids The Nasal Flu Vaccine

6 Reasons I Won’t Give My Kids The Nasal Flu Vaccine

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It’s flu season again, and the push to get everyone in America vaccinated for the flu vaccine is in full swing. Please be aware that those who want you to receive the flu vaccine admittedly do not want you to know about the risks associated with the vaccine. They actively try to suppress information that would educate people on the dangers and risks of the flu vaccine and decrease their sales.

To hear the other side of the vaccine debate from a medical doctor the media would like to censor, please watch the video by Dr. Suzanne Humphries here: Dr. Suzanne Humphries on Vaccine Safety: “They Don’t Want You to Hear the Other Side”

Secondly, please look at the settled cases for vaccine injuries and deaths due to the flu vaccine the U.S. government pays out to victims: Flu Vaccine is the most Dangerous Vaccine in the U. S. based on Settled Cases for Injuries. This information is not published in the mainstream media.

This year, there is a heavy push on to give kids the nasal flu vaccine. Celeste McGovern, writing for GreenMedInfo.com, gives 6 reasons why she will not be giving this vaccine to her children.

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