Latest Drugwonks' Blog
While the comparative effectiveness cabal try to turn patients into cost-centers and forget that you and I real live human beings, the Integrated Benefits Institutes releases a study that brings the human element back to the delivery of healthcare:
"New Integrated Benefits Institute Report Finds Pharmaceutical Cost Shifting Leads to Increased Disability and Lost Productivity
San Francisco – June 27, 2007 – Medical costs, including drug expenditures, have continued to rise much faster than the rate of inflation, causing employers to use strategies to control costs for pharmaceuticals including higher copays, tiered benefit plans and higher deductibles. A new report released today by the nonprofit Integrated Benefits Institute (IBI) reveals that shifting costs to employees doesn’t save employers money and discourages treatment essential to employees’ health-related productivity and quality of life."
Here's a key quote that all the cost-containers in Washington and those who want to set up a comparative effectiveness board should staple to their forehead, carefully, so all the air doesn't escape:
“As employers understand that providing effective, available health care is an investment in human capital that will pay off in real dollars by decreasing overall health-related costs, they may want to rethink their approach to measuring and investing in employee health and productivity,†said Jack Mahoney, MD, medical director at Pitney Bowes. “This is not only good for employers, but employees can benefit from less shifted costs and better health and quality of life.â€
Exactly. Dr. Mahoney articulated the humane, patient centered approach to medicine that the Beltway/Health Affairs/Kaiser/Commonwealth types have turned their backs on. Health care is a human and humane enterprise, not a rationing activity.
Thanks to IBI for restoring a moral and medical compass to the discussion of health care policy.
http://www.ibiweb.org/news/articles/display/7025
"New Integrated Benefits Institute Report Finds Pharmaceutical Cost Shifting Leads to Increased Disability and Lost Productivity
San Francisco – June 27, 2007 – Medical costs, including drug expenditures, have continued to rise much faster than the rate of inflation, causing employers to use strategies to control costs for pharmaceuticals including higher copays, tiered benefit plans and higher deductibles. A new report released today by the nonprofit Integrated Benefits Institute (IBI) reveals that shifting costs to employees doesn’t save employers money and discourages treatment essential to employees’ health-related productivity and quality of life."
Here's a key quote that all the cost-containers in Washington and those who want to set up a comparative effectiveness board should staple to their forehead, carefully, so all the air doesn't escape:
“As employers understand that providing effective, available health care is an investment in human capital that will pay off in real dollars by decreasing overall health-related costs, they may want to rethink their approach to measuring and investing in employee health and productivity,†said Jack Mahoney, MD, medical director at Pitney Bowes. “This is not only good for employers, but employees can benefit from less shifted costs and better health and quality of life.â€
Exactly. Dr. Mahoney articulated the humane, patient centered approach to medicine that the Beltway/Health Affairs/Kaiser/Commonwealth types have turned their backs on. Health care is a human and humane enterprise, not a rationing activity.
Thanks to IBI for restoring a moral and medical compass to the discussion of health care policy.
http://www.ibiweb.org/news/articles/display/7025
From the Daily Sport in the UK
SUBJECT: IF YOU'RE GOING TO BOYCOTT ISRAEL - DO IT PROPERLY!
OK. So I understand that you are ticked off at Israel, and in love with
the Palestinians. That's fine with me, as long as you have truly
weighed all the facts.
So, you want to boycott Israel????? I'll be sorry to miss you, but if
you are doing it - do it properly. Let me help you.
An Israeli company has developed a simple blood test that
distinguishes between mild and more severe cases of Multiple
Sclerosis. So, if you know anyone suffering from MS, tell them to
ignore the Israeli patent that may, more accurately, diagnose their
symptoms.
An Israeli-made device helps restore the use of paralyzed hands. This
device electrically stimulates the hand muscles, providing hope to
millions of stroke sufferers and victims of spinal injuries. If you
wish to remove this hope of a better quality of life to these people,
go ahead and boycott Israel.
Young children with breathing problems will soon be sleeping more
soundly, thanks to a new Israeli device called the Child Hood. This
innovation replaces the inhalation mask with an improved drug delivery
system that provides relief for child and parent. Please tell anxious
mothers that they shouldn't use this device because of your passionate
cause.
These are just a few examples of how people have benefited medically
from the Israeli know-how you wish to block. Boycotts often affect
research.
A new research center in Israel hopes to throw light on brain
disorders such as depression and Alzheimer's disease.
The Joseph Sangol Neuroscience Center in the Sheba Medical Center at
Tel HaShomer Hospital, aims to bring thousands of scientists and
doctors to focus on brain research.
A researcher at Israel's Ben Gurion University has succeeded in
creating human monoclonal antibodies which can neutralize the highly
contagious smallpox virus without inducing the dangerous side effects
of the existing vaccine.
Two Israelis received the 2004 Nobel Prize in Chemistry. Doctors
Ciechanover and Hershko's research and discovery of one of the human
cells most important cyclical processes will lead the way to DNA
repair, control of newly produced proteins, and immune defense
systems.
The Movement Disorder Surgery program at Israel's Hadassah Medical
Center has successfully eliminated the physical manifestations of
Parkinson's disease in a select group of patients with a deep brain
stimulation technique.
For women who undergo hysterectomies each year for the treatment of
uterine fibroids, the development in Israel of the Ex Ablate 2000
System is a welcome breakthrough, offering a noninvasive alternative
to surgery.
Israel is developing a nose drop that will provide a five year flu
vaccine.
These are just a few of the projects that you can help stop with your
Israeli boycott. But let's not get too obsessed with my ducal
research, there are other ways you can make a personal sacrifice with
your anti-Israel boycott.
Most of Windows operating systems were developed by Microsoft-Israel.
So, set a personal example. Throw away your computer!
Computers should have a sign attached saying Israel Inside. The
Pentium NMX Chip technology was designed at Intel in Israel. Both the
Pentium 4 microprocessor and the Centrum processor were entirely
designed, developed, and produced in Israel.
Voice mail technology was developed in Israel.
The technology for the AOL Instant Messenger ICQ was developed in 1996
in Israel by four young Israeli whiz kids.
Both Microsoft and Cisco built their only R. & D. facilities outside
the US in Israel.
So, due to your complete boycott of anything Israeli, you can now
have poor health and no computer.
But your bad news does not end there. Get rid of your cellular phone.
Cell phone technology was also developed in Israel by MOTOROLA which
has its biggest development center in Israel. Most of the latest
technology in your mobile phone was developed by Israeli scientists.
Feeling unsettled? You should be. Part of your personal security rests
with Israeli inventiveness, borne out of our urgent necessity to
protect and defend our lives from the terrorists you support.
A phone can remotely activate a bomb, or be used for tactical
communications by terrorists, bank robbers, or hostage-takers. It is
vital that official security and law enforcement authorities have
access to cellular jamming and detection solutions.
Enter Israel's Net line Communications Technologies with their
security expertise to help the fight against terror.
SO ALL THE NOISE ABOUT THE USA LISTENING TO OUR PRIVATE TELEPHONE
CALLS, YOU SHOULD KNOW IT IS ISRAEL WHO IS DOING THE LISTENING FOR US.
A joint, nonprofit, venture between Israel and Maryland will result in
a 5 day Business Development and Planning Conference next March.
Elected Israeli companies will partner with Maryland firms to provide
innovation to the US need for homeland security.
I also want you to know that Israel has the highest ratio of
university degrees to the population in the world.
Israel produces more scientific papers per capita - 109 per 10,000 -
than any other nation.
Israel has the highest number of startup companies per rata. In
absolute terms, the highest number, except the US. Israel has a ratio
of patents filed.
Israel has the highest concentration of hi-tech companies outside of
Silicon Valley. Israel is ranked #2 in the world for venture capital
funds, behind the USA.
Israel has more museums per capita.
Israel has the second highest publication of new books per capita.
Relative to population, Israel is the largest immigrant absorbing
nation on earth.
These immigrants come in search of democracy, religious freedom or
expression, economic opportunity, and quality of life.
Believe it or not, Israel is the only country in the world which had a
net gain in the number of trees last year.
Even Warren Buffet of Berkshire-Hathaway fame has just invested
millions with Israeli Companies.
So, you can vilify and demonize the State of Israel. You can continue
your silly boycott, if you wish. But I wish you would consider the
consequences, and the truth.
Think of the massive contribution that Israel is giving to the world,
including the Palestinians - and to you - in science, medicine,
communications, security.
Pro rata for population, Israel is making a greater contribution than
any other nation on earth.
SUBJECT: IF YOU'RE GOING TO BOYCOTT ISRAEL - DO IT PROPERLY!
OK. So I understand that you are ticked off at Israel, and in love with
the Palestinians. That's fine with me, as long as you have truly
weighed all the facts.
So, you want to boycott Israel????? I'll be sorry to miss you, but if
you are doing it - do it properly. Let me help you.
An Israeli company has developed a simple blood test that
distinguishes between mild and more severe cases of Multiple
Sclerosis. So, if you know anyone suffering from MS, tell them to
ignore the Israeli patent that may, more accurately, diagnose their
symptoms.
An Israeli-made device helps restore the use of paralyzed hands. This
device electrically stimulates the hand muscles, providing hope to
millions of stroke sufferers and victims of spinal injuries. If you
wish to remove this hope of a better quality of life to these people,
go ahead and boycott Israel.
Young children with breathing problems will soon be sleeping more
soundly, thanks to a new Israeli device called the Child Hood. This
innovation replaces the inhalation mask with an improved drug delivery
system that provides relief for child and parent. Please tell anxious
mothers that they shouldn't use this device because of your passionate
cause.
These are just a few examples of how people have benefited medically
from the Israeli know-how you wish to block. Boycotts often affect
research.
A new research center in Israel hopes to throw light on brain
disorders such as depression and Alzheimer's disease.
The Joseph Sangol Neuroscience Center in the Sheba Medical Center at
Tel HaShomer Hospital, aims to bring thousands of scientists and
doctors to focus on brain research.
A researcher at Israel's Ben Gurion University has succeeded in
creating human monoclonal antibodies which can neutralize the highly
contagious smallpox virus without inducing the dangerous side effects
of the existing vaccine.
Two Israelis received the 2004 Nobel Prize in Chemistry. Doctors
Ciechanover and Hershko's research and discovery of one of the human
cells most important cyclical processes will lead the way to DNA
repair, control of newly produced proteins, and immune defense
systems.
The Movement Disorder Surgery program at Israel's Hadassah Medical
Center has successfully eliminated the physical manifestations of
Parkinson's disease in a select group of patients with a deep brain
stimulation technique.
For women who undergo hysterectomies each year for the treatment of
uterine fibroids, the development in Israel of the Ex Ablate 2000
System is a welcome breakthrough, offering a noninvasive alternative
to surgery.
Israel is developing a nose drop that will provide a five year flu
vaccine.
These are just a few of the projects that you can help stop with your
Israeli boycott. But let's not get too obsessed with my ducal
research, there are other ways you can make a personal sacrifice with
your anti-Israel boycott.
Most of Windows operating systems were developed by Microsoft-Israel.
So, set a personal example. Throw away your computer!
Computers should have a sign attached saying Israel Inside. The
Pentium NMX Chip technology was designed at Intel in Israel. Both the
Pentium 4 microprocessor and the Centrum processor were entirely
designed, developed, and produced in Israel.
Voice mail technology was developed in Israel.
The technology for the AOL Instant Messenger ICQ was developed in 1996
in Israel by four young Israeli whiz kids.
Both Microsoft and Cisco built their only R. & D. facilities outside
the US in Israel.
So, due to your complete boycott of anything Israeli, you can now
have poor health and no computer.
But your bad news does not end there. Get rid of your cellular phone.
Cell phone technology was also developed in Israel by MOTOROLA which
has its biggest development center in Israel. Most of the latest
technology in your mobile phone was developed by Israeli scientists.
Feeling unsettled? You should be. Part of your personal security rests
with Israeli inventiveness, borne out of our urgent necessity to
protect and defend our lives from the terrorists you support.
A phone can remotely activate a bomb, or be used for tactical
communications by terrorists, bank robbers, or hostage-takers. It is
vital that official security and law enforcement authorities have
access to cellular jamming and detection solutions.
Enter Israel's Net line Communications Technologies with their
security expertise to help the fight against terror.
SO ALL THE NOISE ABOUT THE USA LISTENING TO OUR PRIVATE TELEPHONE
CALLS, YOU SHOULD KNOW IT IS ISRAEL WHO IS DOING THE LISTENING FOR US.
A joint, nonprofit, venture between Israel and Maryland will result in
a 5 day Business Development and Planning Conference next March.
Elected Israeli companies will partner with Maryland firms to provide
innovation to the US need for homeland security.
I also want you to know that Israel has the highest ratio of
university degrees to the population in the world.
Israel produces more scientific papers per capita - 109 per 10,000 -
than any other nation.
Israel has the highest number of startup companies per rata. In
absolute terms, the highest number, except the US. Israel has a ratio
of patents filed.
Israel has the highest concentration of hi-tech companies outside of
Silicon Valley. Israel is ranked #2 in the world for venture capital
funds, behind the USA.
Israel has more museums per capita.
Israel has the second highest publication of new books per capita.
Relative to population, Israel is the largest immigrant absorbing
nation on earth.
These immigrants come in search of democracy, religious freedom or
expression, economic opportunity, and quality of life.
Believe it or not, Israel is the only country in the world which had a
net gain in the number of trees last year.
Even Warren Buffet of Berkshire-Hathaway fame has just invested
millions with Israeli Companies.
So, you can vilify and demonize the State of Israel. You can continue
your silly boycott, if you wish. But I wish you would consider the
consequences, and the truth.
Think of the massive contribution that Israel is giving to the world,
including the Palestinians - and to you - in science, medicine,
communications, security.
Pro rata for population, Israel is making a greater contribution than
any other nation on earth.
Peter's post on his importation briefing is Kafka-esque. You can't make up the kind of rationalizations the pro-importation forces have been reduced to -- because they are driven by polls and pure political objective, not facts, not reason, not concern for public health or safety. I think official Washington has created and thrives on a new form of communication, Truthspeak, where flacks, spin doctors, policy hatchets, et al., will say and do anything that advances their short term interests and/or protects their flank though it may contradict reality or what was said or done the day before. The past -- what once was history -- no longer exists and therefore one is no longer accountable or responsible for deeds or actions other than those in the very present.
This tactic has spread Ebola-like throughout politics as the number of media outlets needing content on a 24/7 basis have multiplied.
The importation forces are lead, not coincidentally by Truthspeaker-in-Chief Rahm Emanuel who turned parsing phrases and weasel words into lethal political weapons for the Clintons. (He's had much less success in helping his buddy, Illinois Governor "Wrong-Way Rod" Blagojevich, have any success in the Prairie State's ill-fated importation schemes.)
If you can convince people to open the US to unsafe practices that don't even save money in Europe -- you can do anything. Well, we hope not.
This tactic has spread Ebola-like throughout politics as the number of media outlets needing content on a 24/7 basis have multiplied.
The importation forces are lead, not coincidentally by Truthspeaker-in-Chief Rahm Emanuel who turned parsing phrases and weasel words into lethal political weapons for the Clintons. (He's had much less success in helping his buddy, Illinois Governor "Wrong-Way Rod" Blagojevich, have any success in the Prairie State's ill-fated importation schemes.)
If you can convince people to open the US to unsafe practices that don't even save money in Europe -- you can do anything. Well, we hope not.
Just because you say it enough times doesn't make it true.
Most recent example that proves this maxim is the attempt by certain members of Congress -- in this case U.S. Representatives Rahm Emanuel (D-IL), Jo Ann Emerson (R-MO), Rosa DeLauro (D-CT), and Marion Berry (D-AR) -- to hide the facts that drug importation is neither safe nor smart.
The Fearsome Four offer the following reasons why drug importation is a good idea. (We offer the facts in bold -- because the truth must be told boldly.)
The Fearsome Four claim that the same brand name drugs cost 35-55% less in other nations then they do in the US.
That's because the nation's of the EU (and Canada) have price controls that equal choice controls for their citizens. Also, the rest of the world unfairly shirks its responsibilities to shoulder their fair share of the burden of research and development. This is what members of Congress should be up in arms about.
The Fearsome Four say that drug importation has been in place in the European Union (where they call it "parallel trade") for more than 20 years with no safety problems.
Believe it or not, their "source" for this is Peter Rost. For the truth we prefer the European Commission who has identified parallel trade as the weak link in the chain for counterfeiters. It's also convenient (although not responsible) to forget that the British regulatory authorities have recently found counterfeit and substandard medicines in their island kingdom -- courtesy of parallel trade.
The Fearsome Four claim the pharmaceutical industry has imported drugs and sold them in the U.S. for decades. In fact, 40 percent of the drugs consumed by Americans today are made in foreign manufacturing plants.
That's right -- in plants authorized and inspected by the FDA. The Four conveniently omit the fact that their legislation would allow in medicines from plants not approved by the FDA. Oops.
The Fearsome Four claim that prescription drug importation will result in $50 billion in direct savings alone over the next decade, a $10 billion benefit to the federal budget.
For this fact they cite a Congressional Budget Office Study. But what the study actually says is that such a program woyuld reduce the drug spend in the US by .01%. And that doesn't include the monies needed to set up an entirely new, international system for drug regulation.
And finally, the Fearsome Four claim that passage of the Pharmaceutical Market Access and Drug Safety Act will finally assure the security of our drug supply.
Assure the safety of our drug supply? This is the biggest whopper of them all. How will our domestic medicines supply be "safer" when we open our borders to drugs from Estonia, Latvia, Malta, Greece, and Portugal -- to name only a few. Because what the Fearsome Four aren't saying is that "drugs from the United Kingdom" means drugs from all of the 27 EU nations -- many of which have had their own supply chains infiltrated by counterfeits from Russia and elsewhere. They should do their homework.
What happens when pesky facts get in the way of political grandstanding? Good things.
Most recent example that proves this maxim is the attempt by certain members of Congress -- in this case U.S. Representatives Rahm Emanuel (D-IL), Jo Ann Emerson (R-MO), Rosa DeLauro (D-CT), and Marion Berry (D-AR) -- to hide the facts that drug importation is neither safe nor smart.
The Fearsome Four offer the following reasons why drug importation is a good idea. (We offer the facts in bold -- because the truth must be told boldly.)
The Fearsome Four claim that the same brand name drugs cost 35-55% less in other nations then they do in the US.
That's because the nation's of the EU (and Canada) have price controls that equal choice controls for their citizens. Also, the rest of the world unfairly shirks its responsibilities to shoulder their fair share of the burden of research and development. This is what members of Congress should be up in arms about.
The Fearsome Four say that drug importation has been in place in the European Union (where they call it "parallel trade") for more than 20 years with no safety problems.
Believe it or not, their "source" for this is Peter Rost. For the truth we prefer the European Commission who has identified parallel trade as the weak link in the chain for counterfeiters. It's also convenient (although not responsible) to forget that the British regulatory authorities have recently found counterfeit and substandard medicines in their island kingdom -- courtesy of parallel trade.
The Fearsome Four claim the pharmaceutical industry has imported drugs and sold them in the U.S. for decades. In fact, 40 percent of the drugs consumed by Americans today are made in foreign manufacturing plants.
That's right -- in plants authorized and inspected by the FDA. The Four conveniently omit the fact that their legislation would allow in medicines from plants not approved by the FDA. Oops.
The Fearsome Four claim that prescription drug importation will result in $50 billion in direct savings alone over the next decade, a $10 billion benefit to the federal budget.
For this fact they cite a Congressional Budget Office Study. But what the study actually says is that such a program woyuld reduce the drug spend in the US by .01%. And that doesn't include the monies needed to set up an entirely new, international system for drug regulation.
And finally, the Fearsome Four claim that passage of the Pharmaceutical Market Access and Drug Safety Act will finally assure the security of our drug supply.
Assure the safety of our drug supply? This is the biggest whopper of them all. How will our domestic medicines supply be "safer" when we open our borders to drugs from Estonia, Latvia, Malta, Greece, and Portugal -- to name only a few. Because what the Fearsome Four aren't saying is that "drugs from the United Kingdom" means drugs from all of the 27 EU nations -- many of which have had their own supply chains infiltrated by counterfeits from Russia and elsewhere. They should do their homework.
What happens when pesky facts get in the way of political grandstanding? Good things.
For those of us who enjoy waiting two hours in a doctor's office or using the ER room to getting care because we don't get sick between 10-5, you'll love how the AMA is responding to the grow of retail health clinics:
The American Medical Association should call for a ban on in-store clinics being opened by retail giants like Wal-Mart Stores Inc. and Walgreen Co., several doctors groups urged at the AMA's annual meeting in Chicago on Sunday.
Faced with an onslaught of competition that is forecast to bring several thousand retail health clinics to U.S. consumers, AMA members testified that such clinics are endangering patient care, particularly for children. The doctors say the clinics, largely staffed by advanced-degree nurses and physicians' assistants, are largely unregulated and, therefore, put patients' health at risk.
I have used the Redi-Clinics at Duane Reade and I can tell you MY health was put at risk. I was nearly knocked unconscious by how clean, convenient and excellent the care was. A PA whose previous experience was working at a community health center provided me a flu shot and quick look at my sinuses. She sent a copy of my record via email to me which I shared with my physician. Yeah, a real risk alright.
"There is no more urgent issue than this for the AMA," Dr. Kamran Hashemi, a family physician from South Barrington, said, urging the organization to push for more regulation of retail clinics. "This issue speaks to what all of us do every day in practice." If the AMA does nothing, Hashemi said, "in five years, the chairs [at the AMA] meeting will be filled with representatives from Walgreens, Wal-Mart" and other retail outlets.
It's called competition, Kamran. Get off your chair, change or get out of the way. People in rural areas, who work real jobs, who have sick kids need access to real care in real time, not when it's convenient to doctors who are interested in the status quo. Protectionism is not going to cut it.
http://www.chicagotribune.com/business/chi-clinics_bizjun25,0,4533626.story?coll=chi-business-hed
The American Medical Association should call for a ban on in-store clinics being opened by retail giants like Wal-Mart Stores Inc. and Walgreen Co., several doctors groups urged at the AMA's annual meeting in Chicago on Sunday.
Faced with an onslaught of competition that is forecast to bring several thousand retail health clinics to U.S. consumers, AMA members testified that such clinics are endangering patient care, particularly for children. The doctors say the clinics, largely staffed by advanced-degree nurses and physicians' assistants, are largely unregulated and, therefore, put patients' health at risk.
I have used the Redi-Clinics at Duane Reade and I can tell you MY health was put at risk. I was nearly knocked unconscious by how clean, convenient and excellent the care was. A PA whose previous experience was working at a community health center provided me a flu shot and quick look at my sinuses. She sent a copy of my record via email to me which I shared with my physician. Yeah, a real risk alright.
"There is no more urgent issue than this for the AMA," Dr. Kamran Hashemi, a family physician from South Barrington, said, urging the organization to push for more regulation of retail clinics. "This issue speaks to what all of us do every day in practice." If the AMA does nothing, Hashemi said, "in five years, the chairs [at the AMA] meeting will be filled with representatives from Walgreens, Wal-Mart" and other retail outlets.
It's called competition, Kamran. Get off your chair, change or get out of the way. People in rural areas, who work real jobs, who have sick kids need access to real care in real time, not when it's convenient to doctors who are interested in the status quo. Protectionism is not going to cut it.
http://www.chicagotribune.com/business/chi-clinics_bizjun25,0,4533626.story?coll=chi-business-hed
As its costs continue to spiral upward, most people now agree that America's health care system is broken. And as the race for the White House heats up, politicians on both sides of the aisle are clamoring to propose ideas that rein in health spending.
Unfortunately, the policies offered thus far are misguided. As counterintuitive as it may sound, the answer to America's health care woes won't be found by harping over the price of care.
Here's the rest of the story via a new op-ed in the Baltimore Sun:
http://www.baltimoresun.com/news/opinion/oped/bal-op.prevention24jun24,0,2342454.story?coll=bal-oped-headlines
The conclusion?
"Prevention must be health care's first line of defense, as a proper diet and healthy lifestyle can stop many diseases in their tracks.
Failing prevention, earlier diagnosis and care are crucial. There are many effective treatments and maintenance medications that can stop diseases such as hypertension and diabetes from progressing, allowing millions of Americans to lead active and productive lives without breaking the bank.
In the coming weeks, the nation will learn more about the health care plans of each of the major presidential candidates. If lawmakers want to save lives, enhance the quality of care, and reduce costs, the focus needs to shift to prevention and early diagnosis."
SiCKO? How about WeLLO.
Unfortunately, the policies offered thus far are misguided. As counterintuitive as it may sound, the answer to America's health care woes won't be found by harping over the price of care.
Here's the rest of the story via a new op-ed in the Baltimore Sun:
http://www.baltimoresun.com/news/opinion/oped/bal-op.prevention24jun24,0,2342454.story?coll=bal-oped-headlines
The conclusion?
"Prevention must be health care's first line of defense, as a proper diet and healthy lifestyle can stop many diseases in their tracks.
Failing prevention, earlier diagnosis and care are crucial. There are many effective treatments and maintenance medications that can stop diseases such as hypertension and diabetes from progressing, allowing millions of Americans to lead active and productive lives without breaking the bank.
In the coming weeks, the nation will learn more about the health care plans of each of the major presidential candidates. If lawmakers want to save lives, enhance the quality of care, and reduce costs, the focus needs to shift to prevention and early diagnosis."
SiCKO? How about WeLLO.
Looks like you have to step away from the pharma bloggersphere to find a Kool-aid free zone on Avandia and Nissen:
From http://10qdetective.blogspot.com/
https://www.blogger.com/comment.g?blogID=19852159&postID=4016826588860183126
From http://10qdetective.blogspot.com/
https://www.blogger.com/comment.g?blogID=19852159&postID=4016826588860183126
Thirteen years in the making...GMP requirements for supplements and herbal products.
From http://www.thetansheet.com
Dietary supplement manufacturers will have to be in compliance with newly issued – and long anticipated – dietary supplement good manufacturing practices by June 24, 2008, while the smallest firms will have until June 2010.
FDA posted the regulation for advanced display on the Federal Register June 22, thirteen years after the Dietary Supplement Health and Regulation Act authorized its creation.
The final rule "includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product," FDA notes. The rule also includes "requirements for recordkeeping and handling consumer product complaints."
The rule does not apply to suppliers or producers of raw ingredients, but instead places the onus of GMP compliance completely on manufacturers.
While the rule applies to dietary supplements and not dietary ingredients, any dietary ingredient used in a supplement product will be required to pass "100 percent" identity testing. Firms will be required to verify the identity of any components that are dietary ingredients, and confirm the identity of "other components."
"The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling," said Robert E. Brackett, director of FDA's Center for Food Safety and Applied Nutrition. Under the final rule, manufacturers will be required to "evaluate the identity, purity, strength, and composition of their dietary supplements," the agency says. Supplements that contain contaminants or "do not contain the dietary ingredient they are represented to contain," would be adulterated or misbranded under the rule, FDA says.
Most of this stuff in made overseas or from material shipped overseas. As from China. No coincidence I'm sure. Now let's see how long compliance takes.
From http://www.thetansheet.com
Dietary supplement manufacturers will have to be in compliance with newly issued – and long anticipated – dietary supplement good manufacturing practices by June 24, 2008, while the smallest firms will have until June 2010.
FDA posted the regulation for advanced display on the Federal Register June 22, thirteen years after the Dietary Supplement Health and Regulation Act authorized its creation.
The final rule "includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product," FDA notes. The rule also includes "requirements for recordkeeping and handling consumer product complaints."
The rule does not apply to suppliers or producers of raw ingredients, but instead places the onus of GMP compliance completely on manufacturers.
While the rule applies to dietary supplements and not dietary ingredients, any dietary ingredient used in a supplement product will be required to pass "100 percent" identity testing. Firms will be required to verify the identity of any components that are dietary ingredients, and confirm the identity of "other components."
"The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling," said Robert E. Brackett, director of FDA's Center for Food Safety and Applied Nutrition. Under the final rule, manufacturers will be required to "evaluate the identity, purity, strength, and composition of their dietary supplements," the agency says. Supplements that contain contaminants or "do not contain the dietary ingredient they are represented to contain," would be adulterated or misbranded under the rule, FDA says.
Most of this stuff in made overseas or from material shipped overseas. As from China. No coincidence I'm sure. Now let's see how long compliance takes.
What's up with the FDA issuing an approvable letter on maraviroc? Well according to Peter Rost (who should know since he is the master of manipulating golden parachutes for himself. Rost's next book: How To Collect Fat Paychecks From ShortHills By Suing Those You Work For) it was to allow outgoing Pfizer R and D execs to short their options. Yeah right. And all those imported drugs made in China ARE safe, just like the toothpaste and petfood.
Anyways, if you were an FDA drug reviewer you now have two choices: become a snitch for Senator Grassley or Congressman Waxman or simply wait till the very last minute to approve a drug. You never know when -- in the words of the owner of the Steven E. Nissen Healthy Heart Fund -- you might be approving another 9=11.
Maraviroc was a targeted therapy for people facing multiple drug resistant HIV...but hey, what's a few months while the FDA sorts out an even lower incidence of liver problems than Tylenol? We now live in a country where in some parts you have to be 19 to buy cold medicines with dextromethorphan. That's right folks, you can fight for your country but you can't buy Robitussin.
The infantilization of American continues apace.
Anyways, if you were an FDA drug reviewer you now have two choices: become a snitch for Senator Grassley or Congressman Waxman or simply wait till the very last minute to approve a drug. You never know when -- in the words of the owner of the Steven E. Nissen Healthy Heart Fund -- you might be approving another 9=11.
Maraviroc was a targeted therapy for people facing multiple drug resistant HIV...but hey, what's a few months while the FDA sorts out an even lower incidence of liver problems than Tylenol? We now live in a country where in some parts you have to be 19 to buy cold medicines with dextromethorphan. That's right folks, you can fight for your country but you can't buy Robitussin.
The infantilization of American continues apace.
By now you've surely heard that the E&C vote on the FDA reform package was 39-0 and full House passage looks good.
But ...
The House version has some very dangerous language vis-a-vis advisory committee conflict of interest waivers. The House bill would only permit the FDA to grant one COI waiver per committee.
One? Why not two? Or three? What's the difference? After all, each adcomm member needs to be dealt with as a discreet case, yes?
We can't allow FDA adcomms to be made up of the second best and the almost brightest. Not ever.
Hopefully this can be resolved in conference -- and in the best interest of the public health.
But ...
The House version has some very dangerous language vis-a-vis advisory committee conflict of interest waivers. The House bill would only permit the FDA to grant one COI waiver per committee.
One? Why not two? Or three? What's the difference? After all, each adcomm member needs to be dealt with as a discreet case, yes?
We can't allow FDA adcomms to be made up of the second best and the almost brightest. Not ever.
Hopefully this can be resolved in conference -- and in the best interest of the public health.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
