I commend to your attention the work of Dr. Denise L Faustman et al. See eg pubmed.org faustman dl and pubmed.org ristori + BCG. A useful treatment for autoimmune diseases is to increase the level of TNF alpha rather than decrease it. As many auto mechanics et al know, BCG is safe and inexpensive just like ammunition and munitions. If Sergey Brin wanted to cure autoimmune diseases, Faustman would simply manufacture a peptide and give it to willing volunteers.
I am available to be shot on You Tube with BCG which I have found to be safe and effective for plaque psoriasis. In severe cases of psoriasis, the cardiovascular damage that occurs may be easily reduced by shooting BCG.
Kevin J. Tracey aspires to be a corporation, a person without a soul. Engage him in debate and discussion and let him practice his art on his immediate family.
Opinion
Let Patients Decide How Much Risk They'll Take
Take a tip from Sergey Brin: The health-care regulatory burden stops entrepreneurs from getting into the game.
Updated July 27, 2014 6:44 p.m. ET
Earlier this month, at a private conference for the CEOs of his portfolio companies, venture capitalist
Vinod Khosla
interviewed
Google
GOOGL +0.16%
co-founders
Sergey Brin
and
Larry Page,
asking them if the company might jump into health care. "It's
just a painful business to be in," Mr. Brin replied, later noting that
"the regulatory burden in the U.S. is so high that I think it would
dissuade a lot of entrepreneurs."
Mr.
Brin is right. As a neurosurgeon-scientist and entrepreneur who
co-founded a bioelectronic medicine company that deploys implantable
technology to supplant drugs, I wish he were wrong. But rampant
misalignment of incentives is hampering technology in the U.S. health
industry.
Start with the Food and Drug
Administration, which places the highest premium on "protecting the
public health," according to the agency's website. The agency believes
this goal is best accomplished through detailed oversight, ponderous
review and ultimately control.
Sergey Brin, CEO and co-founder of Google, has said regulatory burden dissuades a lot of entrepreneurs in the U.S.
Reuters
That doesn't work for entrepreneurs
and investors, who want rapid returns on what they invest, at a pace
faster than what the FDA allows. The pharmaceutical industry seeks large
markets with high returns, and the major payers, including insurance
providers, require evidence of cost effectiveness. Physicians and other
prescribers have limited and dwindling resources to participate in
research, and instead are encouraged to push standard treatment
protocols, even when they are of questionable efficacy.
And
the public, the patients, and the parents and children of the
suffering, want treatment to be available, immediate and cheap; free if
possible.
You don't need a postgraduate
degree to realize the problem here. Members of Congress have proposed
reforming the FDA in various ways, urging the agency to speed up its
procedures. These are laudable efforts, but no government agency will
ever be limber enough to mollify the Mr. Brins of this world.
Which
is why it's time to try a new solution. The government and
entrepreneurs should be allowed to carve out their own turf and let
patients choose their own level of risk.
Consider
the case of
Goran Ostovich,
a burly, 47-year-old truck driver from Mostar, Bosnia. Mr.
Ostovich has suffered from long-standing rheumatoid arthritis and needed
near-permanent bed rest. With his hands and wrists swollen and aching,
he could no longer hold on to a wheel or even play with his small
children. He tried a variety of medications. None worked.
When
I met Goran at his doctor's office in 2012, however, he didn't seem at
all afflicted with the disease. That's because, one year earlier, he had
been offered the opportunity to be the first participant in a clinical
trial of a new therapy based on my invention. He received a
bioelectronic implant and rapidly improved. His mobility restored, he
was soon back at work and even sustained an exertion injury from playing
tennis.
Since news of this clinical
trial's success became public, people from all over the U.S. stricken
with rheumatoid arthritis have emailed, called and sent letters pressing
for their shot at potentially effective—but not yet
FDA-approved—treatments. Most wrote that they would gladly travel to
Europe if it meant they could get access to the device.
That's
exactly the point: Some patients are very willing to take a calculated
risk, but misaligned incentives in the industry are driving potential
stakeholders with new solutions out of the business.
While
the FDA does a commendable job, there is no reason it should have the
sole responsibility for access to lifesaving treatment. Institutional
review boards and human-subject research protocols provide extremely
high levels of protection overseeing clinical trials in the U.S. and
Europe. These bodies have weeded out the charlatans in the industry, and
the ultimate determinant of success will be patient satisfaction.
Mr.
Brin and his colleagues took Google public under atypical rules, and to
much fanfare. It is time to apply this kind of boldness to realign
bioelectronic medicine research with clinical needs. Our patients
deserve no less.
Dr. Tracey is a neurosurgeon and CEO of the Feinstein Institute for Medical Research at North Shore-LIJ Health System.
Opinion
Let Patients Decide How Much Risk They'll Take
Take a tip from Sergey Brin: The health-care regulatory burden stops entrepreneurs from getting into the game.
Updated July 27, 2014 6:44 p.m. ET
Earlier this month, at a private conference for the CEOs of his portfolio companies, venture capitalist
Vinod Khosla
interviewed
Google
GOOGL +0.16%
co-founders
Sergey Brin
and
Larry Page,
asking them if the company might jump into health care. "It's
just a painful business to be in," Mr. Brin replied, later noting that
"the regulatory burden in the U.S. is so high that I think it would
dissuade a lot of entrepreneurs."
Mr.
Brin is right. As a neurosurgeon-scientist and entrepreneur who
co-founded a bioelectronic medicine company that deploys implantable
technology to supplant drugs, I wish he were wrong. But rampant
misalignment of incentives is hampering technology in the U.S. health
industry.
Start with the Food and Drug
Administration, which places the highest premium on "protecting the
public health," according to the agency's website. The agency believes
this goal is best accomplished through detailed oversight, ponderous
review and ultimately control.
Sergey Brin, CEO and co-founder of Google, has said regulatory burden dissuades a lot of entrepreneurs in the U.S.
Reuters
That doesn't work for entrepreneurs
and investors, who want rapid returns on what they invest, at a pace
faster than what the FDA allows. The pharmaceutical industry seeks large
markets with high returns, and the major payers, including insurance
providers, require evidence of cost effectiveness. Physicians and other
prescribers have limited and dwindling resources to participate in
research, and instead are encouraged to push standard treatment
protocols, even when they are of questionable efficacy.
And
the public, the patients, and the parents and children of the
suffering, want treatment to be available, immediate and cheap; free if
possible.
You don't need a postgraduate
degree to realize the problem here. Members of Congress have proposed
reforming the FDA in various ways, urging the agency to speed up its
procedures. These are laudable efforts, but no government agency will
ever be limber enough to mollify the Mr. Brins of this world.
Which
is why it's time to try a new solution. The government and
entrepreneurs should be allowed to carve out their own turf and let
patients choose their own level of risk.
Consider
the case of
Goran Ostovich,
a burly, 47-year-old truck driver from Mostar, Bosnia. Mr.
Ostovich has suffered from long-standing rheumatoid arthritis and needed
near-permanent bed rest. With his hands and wrists swollen and aching,
he could no longer hold on to a wheel or even play with his small
children. He tried a variety of medications. None worked.
When
I met Goran at his doctor's office in 2012, however, he didn't seem at
all afflicted with the disease. That's because, one year earlier, he had
been offered the opportunity to be the first participant in a clinical
trial of a new therapy based on my invention. He received a
bioelectronic implant and rapidly improved. His mobility restored, he
was soon back at work and even sustained an exertion injury from playing
tennis.
Since news of this clinical
trial's success became public, people from all over the U.S. stricken
with rheumatoid arthritis have emailed, called and sent letters pressing
for their shot at potentially effective—but not yet
FDA-approved—treatments. Most wrote that they would gladly travel to
Europe if it meant they could get access to the device.
That's
exactly the point: Some patients are very willing to take a calculated
risk, but misaligned incentives in the industry are driving potential
stakeholders with new solutions out of the business.
While
the FDA does a commendable job, there is no reason it should have the
sole responsibility for access to lifesaving treatment. Institutional
review boards and human-subject research protocols provide extremely
high levels of protection overseeing clinical trials in the U.S. and
Europe. These bodies have weeded out the charlatans in the industry, and
the ultimate determinant of success will be patient satisfaction.
Mr.
Brin and his colleagues took Google public under atypical rules, and to
much fanfare. It is time to apply this kind of boldness to realign
bioelectronic medicine research with clinical needs. Our patients
deserve no less.
Dr. Tracey is a neurosurgeon and CEO of the Feinstein Institute for Medical Research at North Shore-LIJ Health System.
Cell Mol Life Sci. 2005 Aug;62(16):1850-62.
The therapeutic potential of tumor necrosis factor for autoimmune disease: a mechanistically based hypothesis.
Abstract
Excess levels of tumor necrosis factor-alpha (TNF-alpha) have been associated with certain autoimmune diseases. Under the rationale that elevated TNF-alpha levels are deleterious, several anti-TNF-alpha therapies are now available to block the action of TNF-alpha in patients with autoimmune diseases with a chronic inflammatory component to the destructive process. TNF-alpha
antagonists have provided clinical benefit to many patients, but their
use also is accompanied by new or aggravated forms of autoimmunity. Here
we propose a mechanistically based hypothesis for the adverse events
observed with TNF-alpha antagonists, and argue for the opposite therapeutic strategy: to boost or restore TNF-alpha
activity as a treatment for some
forms of autoimmunity. Activation defects in the transcription factor nuclear factor kappaB leave autoreactive T cells sensitive to TNF-alpha-induced apoptosis. Treatment with TNF-alpha, by destroying autoreactive T cells, appears to be a highly targeted strategy to interrupt the pathogenesis of type 1 diabetes, lupus and certain forms of autoimmunity.
see faustmanlab.org
forms of autoimmunity. Activation defects in the transcription factor nuclear factor kappaB leave autoreactive T cells sensitive to TNF-alpha-induced apoptosis. Treatment with TNF-alpha, by destroying autoreactive T cells, appears to be a highly targeted strategy to interrupt the pathogenesis of type 1 diabetes, lupus and certain forms of autoimmunity.
see faustmanlab.org
The Faustman Lab at Massachusetts General Hospital
Denise Faustman, MD, PhD, is Director of the Immunobiology
Laboratory at the Massachusetts General Hospital (MGH) and an Associate
Professor of Medicine at Harvard Medical School. Her current research
focuses on discovering and developing new treatments for type 1 diabetes
and other autoimmune diseases, including Crohn's disease, lupus,
scleroderma, rheumatoid arthritis, Sjögren's syndrome, and multiple
sclerosis. She is currently leading a human clinical trial program
testing the efficacy of the BCG vaccine for reversal of long-term type 1
diabetes. Positive results from the Phase I study were reported in 2012.
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