BigPharma and the FDA Re-think Thinking (WSJ)
Mort Zuckerman
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Subject: BigPharma and the FDA Re-think Thinking (WSJ)
Date: Jun 11, 2010 6:51 AM
That's a plan, man.
Here are a few tidbits from
the New World of Immunosuppression/
Badly Cloned B Cells world of LYMErix
disease:
Treat early breast cancer with
antibiotics (a four letter word
according to IDSA):
http://www.ncbi.nlm.nih.gov/pubmed/20520770
Alzheimeritis and TLR2 agonists
like spirochetes (TLR2 is downregulated
in response to myco antigens):
"These data suggest that TLR2 acts as an endogenous receptor for the
clearance of toxic A beta by bone-marrow-derived immune cells. The
cognitive decline is markedly accelerated in a context of TLR2
deficiency. Upregulating this innate immune receptor may then be
considered as a potential new powerful therapeutic approach for AD."
Oral Spirochetes in the brains of Alzheimer's
patients:
http://www.actionlyme.org/BRAIN_PERMANENT.htm
Yep. Too bad Yale had to lie about
Lyme and LYMErix for so many years.
They wrecked discovery in every
major disease for the last 15 years:
http://www.actionlyme.org/index.htm
http://www.actionlyme.org/Pam3Cys_Version15.htm
KMDickson
http://www.actionlyme.org
http://www.relapsingfever.org
=======================================
Drug Makers Will Share Data From Failed Alzheimer's Trials
By SHIRLEY S. WANG
Drug makers' attempts to find treatments for Alzheimer's disease have
produced scant results and a long string of busts. Now a broad effort
is under way to learn something from those failures.
A group of major pharmaceutical companies will share pooled data from
failed clinical trials in an attempt to figure out what is going wrong
in the studies and what can be done to improve drug development.
Experience WSJ professional
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In the first wave, data from 4,000 patients across 11 failed
Alzheimer's-drug clinical trials from Johnson & Johnson,
GlaxoSmithKline PLC, AstraZeneca PLC, Sanofi-Aventis and Abbott
Laboratories will be publicly available as of Friday.
Data from additional drug makers and the National Institutes of Health
will be added in the future. The coalition aims to create similar
pooled databases for Parkinson's disease and tuberculosis, said Marc
Cantillon, executive director of the Coalition against Major Diseases,
which spearheaded the project, funded by the Food and Drug
Administration and Science Foundation Arizona.
The data will be available to all the participating drug makers, as
well as outside researchers with a valid scientific question, Dr.
Cantillon said.
"Companies said they're running into a stone wall with Alzheimer's and
Parkinson's," said Ray Woosley, chief executive of the Critical Path
Institute, which oversees the coalition. "We really believe drugs are
failing because we honestly don't understand the disease."
The hope is that this large database will help answer some questions
that individual trials with just a couple of hundred patients can't
answer, such as how the disease progresses and whether there are
differences in subgroups in the population.
"Innovation no longer happens solely in one company's lab," said Frank
Casty, AstraZeneca's vice president of technical evaluations. "It is
happening through constant interaction between scientists in the
biopharma industry, patient advocates, academia and government."
For the FDA, the project is something of a counter to criticism that
it has been slowing down drug development because it is too focused on
patient safety as opposed to on how well a drug works. Rather than
debate whether the benefit-risk calculation for new drugs should be
changed, the FDA wanted to help the industry develop better methods
for determining if drugs are safe and effective, according to Mark
McClellan, a former FDA commissioner who helped develop and support
the coalition.
"The whole point of this type of effort is to get out of that debate,"
Dr. McClellan said.
FDA Deputy Commissioner Joshua Sharfstein said, "I think the FDA
recognizes that one thing that can accelerate drug development is
sharing information that is relevant to a disease."
If the database works as hoped, it may enable drug makers to build
more sophisticated computer models to help design more efficient
clinical trials that require fewer patients and less money, Dr.
Cantillon said.
With current studies, if the results show no difference between
patients getting an experimental treatment and those getting a
placebo, it often isn't clear if the drug failed or if there was
something wrong in the study design that prevented the effect from
being picked up in the statistical analyses.
The most recent example is Pfizer Inc.'s Dimebon, originally a Russian
cold medicine that had shown promise in treating Alzheimer's patients
in a small, Russian-based trial several years ago. But, a larger,
multinational late-stage study recently showed that the drug had no
effect on this new sample of patients.
"People are left wondering why it didn't work," said Dr. Cantillon.
If a better model could be developed to predict which patients would
respond, "it's possible" that Pfizer could go back and look at
Dimebon's response in those subgroups, he said.
A Pfizer spokesman said the company "is participating in a number of
public-private partnerships with governments, independent medical and
scientific groups, companies and advocacy groups. Collaborations such
as these can lead to more treatment options and better care for
patients and the people who care for them."
Write to Shirley S. Wang at shirle...@wsj.com
"[Real] scientists are *fiercely* independent. That's the good
news."-- NIH's Top Fool, Anthony Fauci