September 16, 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:

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Boy Held by Chicago Hospital in Medical Kidnapping Case Returns Home

Boy Held by Chicago Hospital in Medical Kidnapping Case Returns Home

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Local Fox News affiliate Fox4kc in Kansas City has reported that 17-year-old Isaiah Rider has returned home to Kansas City, even though the State of Illinois still retains his custody rights. Isaiah was released from Luries Children’s Hospital in Chicago where he was being held against his will, and the will of his family. He is reportedly staying with grandparents while his mother fights back against “medical abuse” charges for disagreeing with the hospital’s treatment and wanting to transfer him to a different hospital. Isaiah lost 5 months of his life to confinement in a hospital, and is now anxious to get back to school and resume his life.

Isaiah’s mother Michelle believes they held her son to conduct medical experimentation on his rare disease, Neurofibromatosis. Michelle will return to Chicago Friday to face trial. But in the meantime, at least Isaiah is back home in Kansas City, staying with his grandparents.

Dr. Oz Warns About Mercury in Flu Shots

Dr. Oz Warns About Mercury in Flu Shots

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Dr. Oz spent considerable time covering the issue of thimerosal being used as a preservative in the annual flu vaccine. Thimerosal contains mercury, a well-known neuro-toxin. Dr. Oz interviewed Dr. Mark Hyman and former U.S. Senator and Attorney General Robert F. Kennedy, Jr. on his show to discuss mercury in vaccines.

While it is certainly worthwhile to warn the public of the dangers of mercury in the flu vaccine, Marcella Piper-Terry of VaxTruth.org points out several facts regarding this issue that were not covered during the show, and how Dr. Oz did not exactly get his facts straight on a few things.

Sadly, this is representative of the current level of knowledge concerning vaccines both among the mainstream media and modern-day physicians. Parents of vaccine-damaged children do their homework and research well, and in many cases are more educated on this issue than both the mass media and many doctors.

CDC’s Purchase of $4 Billion of Vaccines a Conflict of Interest in Overseeing Vaccine Safety

CDC’s Purchase of $4 Billion of Vaccines a Conflict of Interest in Overseeing Vaccine Safety

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Do you trust the U.S. Centers for Disease Control (CDC) to oversee vaccine safety, when they have an annual budget of over $4 billion to purchase vaccines from drug companies? In 2015, they want to increase that amount by another half a billion dollars.

Dr. Brian Hooker says the CDC should not be trusted to oversee vaccine safety, and after 10 years of fighting legal battles with the CDC via Freedom of Information requests to secure raw data on vaccine safety studies, he now has solid evidence to back up his claim of fraud within the CDC.

In a shocking news story that rocked the online world but was almost totally ignored by the mainstream media a couple of weeks ago, senior vaccine scientist Dr. William Thompson was revealed as a whistleblower within the CDC, admitting that the CDC had withheld information from a key study in 2004 that supposedly showed that the MMR childhood vaccine was safe.

The CDC was forced to issue a response, and Dr. Hooker has now shown that the CDC response is clearly trying to cover up ethical lapses and explain away key data that was omitted from their original study. This data which was hidden from the public for more than 10 years was not favorable towards their own bias and what they wanted the public to believe about vaccines and autism. Dr. Hooker has clearly shown that the CDC has a conflict of interest, and cannot be trusted with research on vaccine safety when it is spending more than $4 billion of taxpayer funds to purchase vaccines from drug manufacturers.

So what’s next? Will this fraud within the CDC be allowed to continue? There are reports that there are other whistleblowers within the CDC that would like to come forward, but are too fearful at this point. Dr. William Thompson is now represented by one of the top whistleblower attorneys in the nation, and has reportedly turned over more than 1000 documents to Congressman Bill Posey.

The pharmaceutical industry is the richest and most powerful political lobby in the world, however. Will there be enough members of Congress to come forward and oppose them? Does the American public even care enough about this issue to take action and threaten lawmakers who refuse to act and remove vaccine safety oversight from the CDC? Will they demand that taxpayer funds NOT be increased by over a half billion dollars next year to fund the purchase of more vaccines that are produced by pharmaceutical companies who are convicted criminals, and whose products have not been proven safe? More:

Gardasil: The Decision I will Always Regret

Gardasil: The Decision I will Always Regret

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She was full of life UNTIL she received her first and only Gardasil vaccine and this is a decision I regret every second of every day – if only I could turn back the clock!

Bill & Melinda Gates Foundation Vaccine Empire on Trial in India

Bill & Melinda Gates Foundation Vaccine Empire on Trial in India

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While fraud and corruption are revealed on almost a daily basis now in the vaccine industry, the U.S. mainstream media continues to largely ignore such stories. Outside the U.S., however, the vaccine empires are beginning to crumble, and English versions of the news in mainstream outlets are available via the Internet.

One such country is India, where the Bill & Melinda Gates Foundation and their vaccine empire are under fire, including a pending lawsuit currently being investigated by the India Supreme Court. Narayana Kumar of The Economic Times of India has just written a scathing report of fraud and scandals surrounding the Gates vaccine empire: Controversial vaccine studies: Why is Bill & Melinda Gates Foundation under fire from critics in India?

Kumar starts out his 4 page article by focusing on the current case before the India Supreme Court regarding deaths and injuries occurring during drug trials carried out over Merck’s HPV vaccine Gardasil. Vaccine trials were conducted on thousands of girls between the ages of 9 and 15. Many of the girls fell ill, and at least 7 died, and the lawsuit is alleging that in most of these cases, the girls and their parents did not even know what kind of vaccine trial they were participating in.

Unlike the U.S., victims of vaccine harm and fraud will get their day in court as the Supreme Court in India takes up the HPV Gardasil fraud claims. Also unlike the U.S., investigative reporters like Narayana Kumar are doing their job and publishing their findings in the mainstream media, informing the public.

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