August 28, 2014

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

pin it button New Alzheimers Imaging Test Provides NO Benefits, Only Profits for Drug Companies

worthless ct scan New Alzheimers Imaging Test Provides NO Benefits, Only Profits for Drug Companies

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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CDC Whistleblower: Mercury in Vaccines Given to Pregnant Women Linked to Autism

CDC Whistleblower: Mercury in Vaccines Given to Pregnant Women Linked to Autism

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Today, the Autism Media Channel released a short video where CDC whistle-blower Dr. William Thompson states, in a phone call to Dr. Brian Hooker, that injecting mercury into pregnant women creates a “clear and present danger” to the unborn child. Thimerosal, a form of mercury used as a preservative in vaccines, was removed from most childhood vaccines a few years ago, but is still in the annual flu shot, which is recommended for pregnant women.

Dr. Thompson, in the video below, insists that this mercury in vaccines causes “tics” in children, and these tics are 4 times more prevalent in kids with autism. “Tics” are defined on the CDC website as: “Tics are sudden twitches, movements, or sounds that people do repeatedly. People who have tics cannot stop their body from doing these things. For example, a person with a motor tic might keep blinking over and over again. Or, a person with a vocal tic might make a grunting sound unwillingly.”

Watch the short 1 minute video.

CDC Responds: Admits Omitting Vaccine Data Linking Vaccines to Higher Rates of Autism

CDC Responds: Admits Omitting Vaccine Data Linking Vaccines to Higher Rates of Autism

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While the mainstream media continues to ignore what is becoming the biggest news event of the year, the CDC is scrambling to respond to damaging data that they were forced to release earlier this year clearly showing they had data linking vaccines to autism that they hid from the public. This issue can longer be hidden since one of the top researchers within the CDC, who co-authored several of the studies that supposedly showed no link between vaccines and autism, has decided to become a whistle-blower. He has yet to make an official statement, and it is thought that his attorney is seeking official whistle-blower status before he does so.

The CDC, on the other hand, has responded to Dr. Brian Hooker’s newly published study reanalyzing a 2004 CDC study that excluded data showing a significant increase in autism among African American boys who were vaccinated with the MMR vaccine. They supplied a response to the Next News Network, admitting they excluded certain data, and the reasons for doing so. Next News interviewed Dr. Hooker to discuss the CDC response. Dr. Hooker, through a 10-year legal battle with the CDC and hundreds of Freedom of Information requests, finally received the entire data sets from the CDC after Congressman Bill Posey stepped in to put pressure on them to release it. We also now know that Dr. Hooker was in contact for more than a year with an insider in the CDC who has become a whistle-blower, which undoubtedly applied pressure on the CDC to obey the law and release the data.

In this interview, Dr. Hooker states that the CDC is lying in their response, and the reason they are doing so is to protect the reputation of the MMR vaccine. He also points out that the CDC purchases $4 billion of vaccines from the vaccine industry every year, and are the last ones who should be trusted to do studies on vaccine safety due to their huge conflict of interest.

Social Workers Snatch Sick Kids Away from Parents on Fake Diagnosis

Social Workers Snatch Sick Kids Away from Parents on Fake Diagnosis

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The Homeschool Legal Defense Association (HSLDA) helps defend parents who chose to educate their children at home from medical tyranny and abuse. They are a non-profit organization that depends on contributions and membership fees to provide free legal representation. They have successfully litigated cases on parental rights all the way to the U.S. Supreme Court.

HSLDA recently announced they had taken on a case in Virginia where social workers removed two children from the home where they lived with their parents over a fake psychological diagnosis.

Is 16-Year-Old Boy Seized from Mother Being Used in Medical Research?

Is 16-Year-Old Boy Seized from Mother Being Used in Medical Research?

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It has been 4 months since Cook County officials and Lurie Children’s Hospital seized custody of 16-year-old Isaiah Rider from his mother Michelle Rider because she disagreed with his treatment and wanted to transfer him to another hospital.

Isaiah suffers from a condition called neurofibromatosis, and his mother originally brought him to Lurie Children’s Hospital in Chicago because they had specialists on staff trained to treat this disease. But when Isaiah’s condition, which includes severe pain, was not getting any better, she decided to transfer him to a different hospital. As a result, Lurie Children’s Hospital stepped in and seized custody. Isaiah has recorded a video in support of his mother, who he is not allowed to see anymore.

In the report blow by Fox4kc, Michelle explains why she thinks they may be holding Isaiah: to do medical research. The top researchers in the world for neurofibromatosis are at Lurie Children’s Hospital, and the specialists there have previously told her that Isaiah’s case is “very rare.”

Data on Serious Hospital Errors Will Now Be Withheld from the Public

Data on Serious Hospital Errors Will Now Be Withheld from the Public

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Preventable medical mistakes are the third leading cause of death in the US, right after heart disease and cancer, claiming the lives of 210,000 Americans each year. More than two million people are affected by hospital-acquired infections each year, and 75,000-100,000 people die as a result of those infections. The federal government has quietly decided to “solve” the problem of hospital acquired conditions by burying the data.

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