NYT on Outsourcing Drug Trials (Arthur Weinstein and the CDC- “a sorry blend of Monty Python and Big Brother.”)
Mort Zuckerman
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Subject: NYT: The Offshoring of Drug Trials (Like LYMErix in Children)
Date: Feb 19, 2009 5:51 AM
The fake Lyme vaccine that was never found
to prevent Lyme in America, tried on Czech
by the criminal child-assaulters, Larry
Zemel and Henry Feder at UConn:
http://www.actionlyme.org/UCONNS_ABUSE_OF_CZECH_CHILDREN.htm
Watch the movie. It's pretty popular lately
although the scientific proofs are there.
This crime has never been prosecuted, although
you can see with your own eyeballs and confirm
with the FDA that Steere's Lyme cryme in Europe
was a crime:
http://www.relapsingfever.org
I can tell from my site statistics that a certain
person central to all of this, Arthur Weinstein,
is somewhat worried.
Weinstein was involved in the Gary Wormser
ImmuLyme cryme:
http://www.actionlyme.org/DICKSON_FDA_SUBMISSION_FULL.htm
He was also supposedly the "validator" of Steere's
proposal that the more antibodies a person has, the
more scientifically valid the test for too-many
antibodies, when the FDA says "sensitivity" means
Limit of Detection:
http://www.fda.gov/CDER/GUIDANCE/4252fnl.htm
Weinstein proposes that this is a validation of
the Steere RICO CDC Detection Method:
http://www.ncbi.nlm.nih.gov/pubmed/8053960?ordinalpos=5&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum
"The more antibodies, the more valid."
Let's hope he never gets near UNSCOM or is
asked to do any DNA crime analysis. He'd
require ten active TOPOL launchers or the
whole body of the perp instead of just blood
or sperm to detect "evidence are present."
Weinstein also "validated" Klempner's FIQ for
Lyme. The validation showed two different entities:
http://www.ncbi.nlm.nih.gov/pubmed/10513489?ordinalpos=3&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum
In short, with Weinstein at the helm, he'd be
using a radon detector to detect cobalt-60.
A "validation" requires that the "method" detect
only the analyte in question. If it is not
SPECIFIC to the analyte in question, the is not
a "validation" of the method per the FDA's definition.
So, Lyme and LYMErix were never validated, even
by consensus (the Dearborn conference
http://www.actionlyme.org/DEARBORN_WHO_SAID_WHAT.htm
but Weinstein was on that committee, too, to
approve of Steere's IgG proposal, despite no one
even coming close to agreeing with Allen Steere
at that Dearborn conference. Now he is involved
in perpetrating not only a FRAUD on the American
people, he is responsible for UConn going to Europe
with LYMErix and trying out a vaccine that they
not only knew never worked, all the perps admitted
to not even being able to READ their Western Blots
in OspA vaccinated people.
http://www.actionlyme.org/DICKSON_FDA_SUBMISSION_FULL.htm
FOUR TIMES, they admitted they could not tell whether
or not OspA prevented Lyme, yet they all reported
that they had vaccines.
Unless there is a new definition of vaccine, the USDOJ
failed once again, since this is RICO and it involves
some well-known personages who also happen to be
involved in the bankster skits that took down virtually
the whole world:
http://www.actionlyme.org/ALDF_BOARD.htm
American International Group.
I add this because Philip Geraldi agrees with
me that the CIA and the CDC are not working
for Americans but the Captains of Industry:
http://www.amconmag.com/article/2009/feb/23/00020/
“a sorry blend of Monty Python and Big Brother.”
Kathleen M. Dickson
http://www.actionlyme.org
http://www.actionlyme.org
==============================================================
http://www.nytimes.com/2009/02/19/business/19clinic.html?pagewanted=print
February 19, 2009
Outsourcing of Drug Trials Is Faulted
By NATASHA SINGER
As many American companies in the last decade have sent tasks like
customer service and computer support to other countries, drug makers
have followed suit by outsourcing clinical trials — the human studies
that determine the safety and efficacy of medicines.
Now, an article about the globalization of clinical trials, published
Thursday in The New England Journal of Medicine raises questions about
the ethics and the science of increasingly conducting studies outside
the United States — when the studies are meant to gather evidence for
new drugs to gain approval in this country.
The article, by several Duke University researchers, suggests an
ethical quagmire when drugs intended for wealthy nations are tested on
people in developing countries. The authors suggest that human
volunteers in foreign countries may be unduly influenced with the
promise of financial compensation or free medical care to participate
in clinical trials.
The report, “Ethical and Scientific Implications of the Globalization
of Clinical Research,” also asks whether drug research conducted in
developing countries is relevant to the treatment of American
patients.
“We don’t want to imagine that lower-income countries are the clinical
trial mill for higher-income countries,” Dr. Kevin A. Schulman, the
lead author of the article, said in a phone interview last week. Dr.
Schulman is a professor of medicine at the Fuqua School of Business at
Duke, in Durham, N.C.
But some critics say the authors used overly simplistic data mining to
raise an alarm, without presenting hard evidence of widespread ethical
or scientific problems.
“More places outside the United States are participating in research —
is that a bad thing?” said Dr. Ezekiel J. Emanuel, the chairman of
bioethics at the Clinical Center of the National Institutes of Health
in Bethesda, Md., after reading an abstract of the article sent to him
by a reporter.
Dr. Emanuel cited a clinical trial of the Merck drug Gardasil, a
vaccine against the human papilloma virus, that was conducted in Costa
Rica, where there is a high incidence of the disease. “This is the
kind of case where it is a good thing.”
Whatever the interpretations, the use of offshore clinical trials is
growing. In the last 10 years, the proportion of United States-based
researchers who direct clinical trials registered with the federal
Food and Drug Administration has declined significantly, while the
percentage of F.D.A.-registered researchers outside the United States
has significantly increased, according to a report in January by the
Tufts Center for the Study of Drug Development in Boston.
In 1997, about 86 percent of F.D.A.-registered principal investigators
were based in the United States, the Tufts study said. By 2007, only
about 54 percent of about 26,000 F.D.A.-regulated chief scientists who
conducted clinical trials that year were based in the United States.
Kenneth A. Getz, a senior research fellow at the Tufts center, said
drug companies were looking abroad because it was often less expensive
to conduct clinical trials outside the United States, and it was
easier to find a large group of study subjects who had never been
treated with medications.
Critics of the Duke article take issue with its methodology. The
authors, for example, compare the locations of 300 clinical trials
published in three leading medical journals in 1995 and 2005,
concluding that the number of countries participating in studies more
than doubled over that decade.
But critics question that comparison, because about 40 percent of the
published clinical trials from 1995 did not indicate where the studies
were conducted.
One of the authors, Dr. Seth W. Glickman, a senior scholar at the
Fuqua School of Business at Duke, said he did not know how omitting
those studies might have skewed the analysis.
And although the article uses the country statistics to raise concerns
about the increased globalization of clinical research, the Tufts
study shows that the majority of F.D.A.-regulated drug researchers are
still in the United States. Offshore researchers, moreover, are
represented largely by Western Europe and middle-income countries in
Eastern Europe and Latin America, according to the Tufts data.
The Duke authors also write that drug research in developing countries
— where certain populations may metabolize medications differently
because of environmental factors or genetic mutations — might not be
relevant for American patients. “There are issues with the
interpretability of the findings,” Dr. Glickman said.
Dr. Emanuel of the N.I.H. agreed that it was possible that some
offshore drug research might not be applicable to American patients.
But he faulted the report for seeming to treat all foreign countries
alike. Research conducted in some places outside the United States —
like Canada and Sweden — might be perfectly relevant to American
patients, he said.
“It’s not a sufficiently nuanced concern to give it credibility,” said
Dr. Emanuel.