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Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
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Instapundit
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Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
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03/10/2008 07:27 AM |
The House Energy and Commerce Committee's health subcommittee is scheduled to pick up Tuesday where it left off Thursday, discussing and possibly amending the tobacco-control legislation before certain passage. The full committee would then take up the bill, and passage there appears certain as well.
Then it's on to the House, where a bit more than half its members (220, to be precise) are co-sponsors of the bill. In the Senate, similar legislation has 56 co-sponsors – including Senators McCain, Clinton, and Obama.
Is cigarette smoking deleterious to America's health. Absolutely. Should Americans who currently smoke quit? Absolutely. Should the FDA regulate tobacco products? Absolutely not.
One major problem with the proposed legislation is that it sets a very high bar (both scientific and procedural) before the FDA could approve a claim of "modified risk." The impact here would be to reduce any tobacco company's ability (or, most probably, desire) to promote their brands that are lower in nicotine content or, indeed, to even develop such products.
Or consider this, adult smoking has been declining since 1997 due to a number of things including clean air laws, media campaigns, and youth access programs. And these victories were achieved on the state level. If FDA became the nation's tobacco czar, it would become difficult if not impossible (given today’s economic circumstances) to convince state legislators to continue to allocate the funds required for robust state-level tobacco control programs.
Then, of course, there's the question of both FDA resources and expertise. Let's take the latter first. What is the current level of FDA expertise in tobacco regulation? Zero. As far as resources are concerned, the FDA's tobacco program would be funded by user fees. And, considering the current state of FDA funding and staffing, you have to ask yourself if this is really the way we want to be going.
So, when you consider all of these issues, the answer to "Will FDA regulation of tobacco help to reduce tobacco use in America?" is very much an open one.
So for now, thank you for not regulating.
FYI -- the Center for Medicine in the Public Interest (the sponsor of drugwonks.com) does not accept funding from the tobacco industry. Read More & Comment...
Then it's on to the House, where a bit more than half its members (220, to be precise) are co-sponsors of the bill. In the Senate, similar legislation has 56 co-sponsors – including Senators McCain, Clinton, and Obama.
Is cigarette smoking deleterious to America's health. Absolutely. Should Americans who currently smoke quit? Absolutely. Should the FDA regulate tobacco products? Absolutely not.
One major problem with the proposed legislation is that it sets a very high bar (both scientific and procedural) before the FDA could approve a claim of "modified risk." The impact here would be to reduce any tobacco company's ability (or, most probably, desire) to promote their brands that are lower in nicotine content or, indeed, to even develop such products.
Or consider this, adult smoking has been declining since 1997 due to a number of things including clean air laws, media campaigns, and youth access programs. And these victories were achieved on the state level. If FDA became the nation's tobacco czar, it would become difficult if not impossible (given today’s economic circumstances) to convince state legislators to continue to allocate the funds required for robust state-level tobacco control programs.
Then, of course, there's the question of both FDA resources and expertise. Let's take the latter first. What is the current level of FDA expertise in tobacco regulation? Zero. As far as resources are concerned, the FDA's tobacco program would be funded by user fees. And, considering the current state of FDA funding and staffing, you have to ask yourself if this is really the way we want to be going.
So, when you consider all of these issues, the answer to "Will FDA regulation of tobacco help to reduce tobacco use in America?" is very much an open one.
So for now, thank you for not regulating.
FYI -- the Center for Medicine in the Public Interest (the sponsor of drugwonks.com) does not accept funding from the tobacco industry. Read More & Comment...
03/09/2008 03:52 PM |
Leave it to the mainstream media to pump out the ultimate scare: Big Pharma pollutes the water supply!!!!
AP probe finds drugs in drinking water
By JEFF DONN, MARTHA MENDOZA and JUSTIN PRITCHARD, Associated Press Writers
"A vast array of pharmaceuticals — including antibiotics, anti-convulsants, mood stabilizers and sex hormones — have been found in the drinking water supplies of at least 41 million Americans, an Associated Press investigation shows."
What no Viagra? What about OTC products? Is this some off-label use conspiracy?
"To be sure, the concentrations of these pharmaceuticals are tiny, measured in quantities of parts per billion or trillion, far below the levels of a medical dose. Also, utilities insist their water is safe."
Trillion? How about gazillion?
"But the presence of so many prescription drugs — and over-the-counter medicines like acetaminophen and ibuprofen — in so much of our drinking water is heightening worries among scientists of long-term consequences to human health."
Which scientists? I don't think AP could find one to comment...or at least one that wouldn't stop laughing long enough to do so.
"And while researchers do not yet understand the exact risks from decades of persistent exposure to random combinations of low levels of pharmaceuticals, recent studies — which have gone virtually unnoticed by the general public — have found alarming effects on human cells and wildlife."
Yes, truly alarming, especially when you claim we don't know the risks.
"We recognize it is a growing concern and we're taking it very seriously," said Benjamin H. Grumbles, assistant administrator for water at the U.S. Environmental Protection Agency."
Yes and so does I.M. Krankee assistant administrator for administrators at the EPA.
The evidence is overwhelming. The AP actually conducted a 5 month investigation.
Most significant:
"Anti-anxiety medications were detected in a portion of the treated drinking water for 18.5 million people in Southern California.A sex hormone was detected in San Francisco's drinking water."
Why am I not surprised. But no cocaine, pot or heroin? Are those drugs too?
The rest of the article breathlessly details the peril parts per trillion pharmaceuticals impose on the planet. It ends with this observation:
"We know we are being exposed to other people's drugs through our drinking water, and that can't be good," says Dr. David Carpenter, who directs the Institute for Health and the Environment of the State University of New York at Albany."
Very scientific judgment David. I know some people who should be drinking heavily...or have been. It's the birdbrains at AP who put this story together...
Read Article Here
Read More & Comment...
AP probe finds drugs in drinking water
By JEFF DONN, MARTHA MENDOZA and JUSTIN PRITCHARD, Associated Press Writers
"A vast array of pharmaceuticals — including antibiotics, anti-convulsants, mood stabilizers and sex hormones — have been found in the drinking water supplies of at least 41 million Americans, an Associated Press investigation shows."
What no Viagra? What about OTC products? Is this some off-label use conspiracy?
"To be sure, the concentrations of these pharmaceuticals are tiny, measured in quantities of parts per billion or trillion, far below the levels of a medical dose. Also, utilities insist their water is safe."
Trillion? How about gazillion?
"But the presence of so many prescription drugs — and over-the-counter medicines like acetaminophen and ibuprofen — in so much of our drinking water is heightening worries among scientists of long-term consequences to human health."
Which scientists? I don't think AP could find one to comment...or at least one that wouldn't stop laughing long enough to do so.
"And while researchers do not yet understand the exact risks from decades of persistent exposure to random combinations of low levels of pharmaceuticals, recent studies — which have gone virtually unnoticed by the general public — have found alarming effects on human cells and wildlife."
Yes, truly alarming, especially when you claim we don't know the risks.
"We recognize it is a growing concern and we're taking it very seriously," said Benjamin H. Grumbles, assistant administrator for water at the U.S. Environmental Protection Agency."
Yes and so does I.M. Krankee assistant administrator for administrators at the EPA.
The evidence is overwhelming. The AP actually conducted a 5 month investigation.
Most significant:
"Anti-anxiety medications were detected in a portion of the treated drinking water for 18.5 million people in Southern California.A sex hormone was detected in San Francisco's drinking water."
Why am I not surprised. But no cocaine, pot or heroin? Are those drugs too?
The rest of the article breathlessly details the peril parts per trillion pharmaceuticals impose on the planet. It ends with this observation:
"We know we are being exposed to other people's drugs through our drinking water, and that can't be good," says Dr. David Carpenter, who directs the Institute for Health and the Environment of the State University of New York at Albany."
Very scientific judgment David. I know some people who should be drinking heavily...or have been. It's the birdbrains at AP who put this story together...
Read Article Here
Read More & Comment...
03/07/2008 03:51 PM |
What constitutes a "complete and reviewable" submission for DDMAC review of a DTC ad?
For a complete answer, see here:
http://www.fda.gov/cder/ddmac/submissions.htm
And for an insight into regulatory creep, consider this little codicil:
"Spokesperson verification – i.e., verification that a person who is held out as either being an actual patient or actual doctor is in fact a real patient or real doctor. Verification should consist of a signed statement from the spokesperson certifying that the claims they make in the piece about being a doctor/being a patient and actually prescribing or using the drug are accurate."
This is nothing more than a knee-jerk "PJ" ("Post-Jarvik") reaction. And DDMAC should know better. What does this have to do with fair balance or adequate provision? Nothing. What does it have to do with politics. Everything.
After all, what pharmaceutical company in their right mind would represent a "fake" doctor as a real one. Regarless of what you feel about the industry or DTC -- you must admit that the answer is -- none. That's why there have been precisely zero DDMAC actions on this front.
Verifiable? How about verifiably inane. Read More & Comment...
For a complete answer, see here:
http://www.fda.gov/cder/ddmac/submissions.htm
And for an insight into regulatory creep, consider this little codicil:
"Spokesperson verification – i.e., verification that a person who is held out as either being an actual patient or actual doctor is in fact a real patient or real doctor. Verification should consist of a signed statement from the spokesperson certifying that the claims they make in the piece about being a doctor/being a patient and actually prescribing or using the drug are accurate."
This is nothing more than a knee-jerk "PJ" ("Post-Jarvik") reaction. And DDMAC should know better. What does this have to do with fair balance or adequate provision? Nothing. What does it have to do with politics. Everything.
After all, what pharmaceutical company in their right mind would represent a "fake" doctor as a real one. Regarless of what you feel about the industry or DTC -- you must admit that the answer is -- none. That's why there have been precisely zero DDMAC actions on this front.
Verifiable? How about verifiably inane. Read More & Comment...
03/07/2008 11:33 AM |
Here's Sir Michael Rawlins, the director of NICE, exposing comparative effectiveness as a back of the envelope calculation that has hardened into a tool for rationing:
" It is not based on empirical research, there is no empirical research anywhere in the world, it is really based on the collective judgment of the health economists we have approached across the country. There is no known piece of work which tells you what the threshold should be. There have been ex cathedra statements. For example, the World Health Organisation says it should be somewhere around your GDP per person, but why the GDP per capita? It is elusive."
Who do you trust, your doctor or the collective judgment of health economists and their ex cathedra statements..... Policymakers who support comparative effectiveness as evidence-based are engaging in Orwellian Newspeak.
Read more of the sloppy methodology deployed by cost containers....
http://www.publications.parliament.uk/pa/cm200708/cmselect/cmhealth/uc27-i/uc2702.htm Read More & Comment...
" It is not based on empirical research, there is no empirical research anywhere in the world, it is really based on the collective judgment of the health economists we have approached across the country. There is no known piece of work which tells you what the threshold should be. There have been ex cathedra statements. For example, the World Health Organisation says it should be somewhere around your GDP per person, but why the GDP per capita? It is elusive."
Who do you trust, your doctor or the collective judgment of health economists and their ex cathedra statements..... Policymakers who support comparative effectiveness as evidence-based are engaging in Orwellian Newspeak.
Read more of the sloppy methodology deployed by cost containers....
http://www.publications.parliament.uk/pa/cm200708/cmselect/cmhealth/uc27-i/uc2702.htm Read More & Comment...
03/07/2008 08:28 AM |
Straight shooting from the Washington Post editorial page. And we concur.
Some snippets:
"The FDA has been scolded about this yawning loophole in drug safety for over a decade but has not acted to fill it. Funding is the main problem."
We've been saying this for years and welcome the Post to the fold. Passage of FD Triple A is a giant step in the right direction -- but it is only a first step. Our elected representatives must stay focussed, tone down the rhetoric, and keep their eye on the prize. All of the wasted time and energy being spent trash talking biomarkers and posturing around the Reagan/Udall Foundation would be time and energy better spent addressing FDA's critical funding priorities.
"Without good data, there's no way to create an accurate, risk-based enforcement model, and no way for FDA officials to be held accountable."
It's not sexy -- but this is where the rubber meets the road. The FDA is at the intersection of life-saving data. Now is the time to make it happen via robust IT systems.
"The FDA very evidently needs more money, either through appropriations or user fees (which under current law can't be used for follow-up surveillance inspections). How much is unclear, since FDA officials won't say how much more in the way of money or inspectors is needed to carry out their expanding mission, claiming it's not their job to decide. We don't know whether their silence is attributable to their shyness or threats from the Bush administration. But when the safety of the American public is being risked by their financial inability to do their jobs, they need to speak up. That's the only way lawmakers -- who last year gave the FDA more money than the Bush administration had asked for -- can relieve FDA officials of their remaining excuses for nonperformance."
Yup.
Here's a link to the complete editorial:
http://www.washingtonpost.com/wp-dyn/content/article/2008/03/06/AR2008030603457.html
It shouldn't take tragic events, such as deaths due to counterfeit drugs, to make this happen. But if that's what it takes to get it done, then let's honor the victims by making real FDA reform a bipartisan public health victory.
Now. Read More & Comment...
Some snippets:
"The FDA has been scolded about this yawning loophole in drug safety for over a decade but has not acted to fill it. Funding is the main problem."
We've been saying this for years and welcome the Post to the fold. Passage of FD Triple A is a giant step in the right direction -- but it is only a first step. Our elected representatives must stay focussed, tone down the rhetoric, and keep their eye on the prize. All of the wasted time and energy being spent trash talking biomarkers and posturing around the Reagan/Udall Foundation would be time and energy better spent addressing FDA's critical funding priorities.
"Without good data, there's no way to create an accurate, risk-based enforcement model, and no way for FDA officials to be held accountable."
It's not sexy -- but this is where the rubber meets the road. The FDA is at the intersection of life-saving data. Now is the time to make it happen via robust IT systems.
"The FDA very evidently needs more money, either through appropriations or user fees (which under current law can't be used for follow-up surveillance inspections). How much is unclear, since FDA officials won't say how much more in the way of money or inspectors is needed to carry out their expanding mission, claiming it's not their job to decide. We don't know whether their silence is attributable to their shyness or threats from the Bush administration. But when the safety of the American public is being risked by their financial inability to do their jobs, they need to speak up. That's the only way lawmakers -- who last year gave the FDA more money than the Bush administration had asked for -- can relieve FDA officials of their remaining excuses for nonperformance."
Yup.
Here's a link to the complete editorial:
http://www.washingtonpost.com/wp-dyn/content/article/2008/03/06/AR2008030603457.html
It shouldn't take tragic events, such as deaths due to counterfeit drugs, to make this happen. But if that's what it takes to get it done, then let's honor the victims by making real FDA reform a bipartisan public health victory.
Now. Read More & Comment...
03/06/2008 09:15 PM |
The National Vaccine Injury Compensation Program (NVIP) board voted to award a family monetary compensation in a case where the reviewers determined that the family was able to show -- not prove, not demonstrate on the basis of scientific evidence -- that it was not impossible to rule out that vaccines aggravated a rare mitochonrial disease (MD). MD is associated with systemic toxicity and nutrient starvation issues at the cellular level that can lead to developmental delays, brain damage and behaviors consistent with those found on the autism disorder spectrum.
Thus, under the very loose evidentiary standards of the NVIP under which a claim may have merit without proof of strong association or causation, the family won an award. That is all the family had to do was show that the vaccines were given around the time the mitochondrial disorder was aggravated.
Now the facts, ignored by the media and, it appears, the special masters reviewing the case:
1. Mitochondrial dysfunction may be one of the most common medical conditions associated with autism.
2. Autistic features are associated with MD. So are developmental delays.
3. There is a high frequency of biochemical markers of mitochondrial dysfunction namely hyperlactacidemia and increased lactate/pyruvate ratio in a small sample of autistic families. But there is no direct linkage between the two markers. (Am J Psychiatry. 2006 May;163(5):929-31. Lack of association between autism and SLC25A12.)
4.Instead, population studies show simply an association: definite mitochondrial respiratory chain disorder, suggesting that this might be one of the most common disorders associated with autism, about 7.2 percent in one study. (Mitochondrial dysfunction in autism spectrum disorders: a population-based study. Dev Med Child Neurol. 2005 Mar;47(3):185-9.Click here to read)
5. There are no scientific studies documenting that childhood vaccinations cause mitochondrial diseases or worsen mitochondrial disease symptoms. In the absence of scientific evidence, the UMDF cannot confirm any association between mitochondrial diseases and vaccines.
But you don't have to bring science to bear in the NVIP, only a plausible basis for a claim which can be little more than a hypothesis that dramatizes risk. In the 1980s parents who sued for compensation for brain damage due to DTP vaccine won even though the did not prove an association and scientists said there was none. Sound familar?
So is this a "victory" for the vaccine-autism stalwarts. It was an ingenious approach taken by the parents and the autism fringe groups. They know the media and it's inability to assess the science and desire to portray suffering parents as triumphant over the government and vaccine companies. So my guess is it is. It is a loss for science and the public health. Read More & Comment...
Thus, under the very loose evidentiary standards of the NVIP under which a claim may have merit without proof of strong association or causation, the family won an award. That is all the family had to do was show that the vaccines were given around the time the mitochondrial disorder was aggravated.
Now the facts, ignored by the media and, it appears, the special masters reviewing the case:
1. Mitochondrial dysfunction may be one of the most common medical conditions associated with autism.
2. Autistic features are associated with MD. So are developmental delays.
3. There is a high frequency of biochemical markers of mitochondrial dysfunction namely hyperlactacidemia and increased lactate/pyruvate ratio in a small sample of autistic families. But there is no direct linkage between the two markers. (Am J Psychiatry. 2006 May;163(5):929-31. Lack of association between autism and SLC25A12.)
4.Instead, population studies show simply an association: definite mitochondrial respiratory chain disorder, suggesting that this might be one of the most common disorders associated with autism, about 7.2 percent in one study. (Mitochondrial dysfunction in autism spectrum disorders: a population-based study. Dev Med Child Neurol. 2005 Mar;47(3):185-9.Click here to read)
5. There are no scientific studies documenting that childhood vaccinations cause mitochondrial diseases or worsen mitochondrial disease symptoms. In the absence of scientific evidence, the UMDF cannot confirm any association between mitochondrial diseases and vaccines.
But you don't have to bring science to bear in the NVIP, only a plausible basis for a claim which can be little more than a hypothesis that dramatizes risk. In the 1980s parents who sued for compensation for brain damage due to DTP vaccine won even though the did not prove an association and scientists said there was none. Sound familar?
So is this a "victory" for the vaccine-autism stalwarts. It was an ingenious approach taken by the parents and the autism fringe groups. They know the media and it's inability to assess the science and desire to portray suffering parents as triumphant over the government and vaccine companies. So my guess is it is. It is a loss for science and the public health. Read More & Comment...
03/06/2008 01:46 PM |
Can ignorance be bliss when it comes to information about your health? Is knowledge always power -- and can that power be abused? And what about the need for more robust FDA oversight of 21st centuty diagnostics?
Have a look at this article from today's edition of USA Today:
Companies cash in on checking your DNA for disease
By Rita Rubin, USA TODAY
Several new companies are betting consumers will be curious enough to shell out $1,000 or more to learn what diseases might lurk in their genes.
Using a half-teaspoon of saliva, collected at home and mailed to a lab, companies with catchy names such as de-CODEme and 23andME (for humans' 23 chromosomes) are selling the chance to peer into one's genome, the hereditary information encoded in DNA.
Q&A: What to know about testing your genes
The Genetics and Public Policy Center in Washington, D.C., has identified eight companies marketing a "personal genome service." They test for common gene variations linked to a higher risk of leading killers such as heart disease. Other firms market tests to detect genetic susceptibility to specific conditions; one for late-onset Alzheimer's is due this spring.
TEST: Tell if you're destined for Alzheimer's ... then what?
YOUR VIEW: Would you get tested for serious disease and live your life differently?
The tests raise a host of ethical and practical questions: Why should people be tested to see whether they're at risk for a disease they can't do anything about? What will they do with their results? What safeguards are in place to protect their privacy?
In The New England Journal of Medicine on Jan. 10, Harvard epidemiologist David Hunter, Muin Khoury of the Centers for Disease Control and Prevention and Journal editor Jeffrey Drazen called efforts to popularize genetic testing "premature." The diseases listed by test sellers involve multiple gene variations — many of which aren't yet known — that interact with each other and the environment, they say.
Linda Avey, who is co-founder of 23andMe in Mountain View, Calif., disagrees. "The debate is sort of over," she says. "There's so much interest and pent-up demand for this." Her firm charges $999 for a genetic profile. She won't say how many customers have paid for the test.
Among the more targeted tests, HairDX in Irvine, Calif., says for $149 it can tell men whether they're likely to start balding at 40 so they can "make the right decisions to preserve" their hair. Then there is Alzheimer's Mirror, which tests for the one known genetic risk factor for late-onset Alzheimer's.
"My big concern is that these tests are massively under-regulated," says Kathy Hudson, director of the Genetics and Public Policy Center. "There's nobody looking seriously at whether the claims these companies are making about the tests are accurate." Read More & Comment...
Have a look at this article from today's edition of USA Today:
Companies cash in on checking your DNA for disease
By Rita Rubin, USA TODAY
Several new companies are betting consumers will be curious enough to shell out $1,000 or more to learn what diseases might lurk in their genes.
Using a half-teaspoon of saliva, collected at home and mailed to a lab, companies with catchy names such as de-CODEme and 23andME (for humans' 23 chromosomes) are selling the chance to peer into one's genome, the hereditary information encoded in DNA.
Q&A: What to know about testing your genes
The Genetics and Public Policy Center in Washington, D.C., has identified eight companies marketing a "personal genome service." They test for common gene variations linked to a higher risk of leading killers such as heart disease. Other firms market tests to detect genetic susceptibility to specific conditions; one for late-onset Alzheimer's is due this spring.
TEST: Tell if you're destined for Alzheimer's ... then what?
YOUR VIEW: Would you get tested for serious disease and live your life differently?
The tests raise a host of ethical and practical questions: Why should people be tested to see whether they're at risk for a disease they can't do anything about? What will they do with their results? What safeguards are in place to protect their privacy?
In The New England Journal of Medicine on Jan. 10, Harvard epidemiologist David Hunter, Muin Khoury of the Centers for Disease Control and Prevention and Journal editor Jeffrey Drazen called efforts to popularize genetic testing "premature." The diseases listed by test sellers involve multiple gene variations — many of which aren't yet known — that interact with each other and the environment, they say.
Linda Avey, who is co-founder of 23andMe in Mountain View, Calif., disagrees. "The debate is sort of over," she says. "There's so much interest and pent-up demand for this." Her firm charges $999 for a genetic profile. She won't say how many customers have paid for the test.
Among the more targeted tests, HairDX in Irvine, Calif., says for $149 it can tell men whether they're likely to start balding at 40 so they can "make the right decisions to preserve" their hair. Then there is Alzheimer's Mirror, which tests for the one known genetic risk factor for late-onset Alzheimer's.
"My big concern is that these tests are massively under-regulated," says Kathy Hudson, director of the Genetics and Public Policy Center. "There's nobody looking seriously at whether the claims these companies are making about the tests are accurate." Read More & Comment...
03/05/2008 03:39 PM |
Since death is a surrogate for advancing to the next stage of Man's destiny, Senator Grassley should ask the GAO to investigate whether Pharma, in conspiracy with the FDA, is thwarting God's plan. Read More & Comment...
03/05/2008 02:32 PM |
So now Senator Grassley wants the GAO to determine whether or not using surrogate markers is sound science?
This isn't about the scope of science -- it's a newest phase of the current FDA Scope's Monkey Trial.
And the patient shall inherit the wind. Read More & Comment...
This isn't about the scope of science -- it's a newest phase of the current FDA Scope's Monkey Trial.
And the patient shall inherit the wind. Read More & Comment...
03/04/2008 05:54 PM |
MA Senate President Therese Murray wants to ban all gifts, grants and honoraria to physicians. You can go to jail and be fined $5000 for giving a talk sponsored by the biotech or drug company. Take a pen and go to the pen. Two years max.
All designed to control health care spending. So let's see. Drug spending is 11 percent of total health care dollars -- and is rising less rapidly than other expenditures -- and generic drug scrips are rising much more rapidly in every major chronic disease area. Yeah, criminalizing the private actions of MDs with respect to drug companies will really bring medical costs to a screeching halt.
I wonder what the conflict of interest police on the web think about that. Giddy with the thought of eager trial attorneys and regulatory agencies sticking it to Big Phrma...
And speaking of conflicts, which Sen. Murray made much of in introducing her bill, those who live in the Bay State might want to know that Murray is a key supporter of 40T which would allow people like her to appoint unelected special districts to take property and raise taxes for private development projects..
" Within the district, an appointed panel, handpicked by the developers, would replace many of the functions of elected municipal officials. They could raise taxes ("assessments") without regard to the constraints of Proposition 2 1/2. They could pass their own bylaws. A vote of their unelected panel would replace any requirement in Massachusetts law for a democratic vote of the people within the district. In effect, this bill creates new towns within towns in which democracy and public purpose are replaced by the rule of unelected officials with a profit motive.
Chapter 40T turns the concept of conflict of interest on its head because government powers would be blatantly exercised to enrich private parties. By evading democratic checks and balances, it offers unlimited opportunities for abuse."
http://www.masschc.org/chapter40T.html
No potential for conflict there.... I wonder who contributed to her campaign?
But watch the connect the dot crowd ignore the hypocrisy and double standards of the pols who want to put physicians on a watch list.
http://www.boston.com/news/local/articles/2008/03/04/ban_on_gifts_to_doctors_sought/
The conflict of interest movement is morphing into a lynch mob.. Read More & Comment...
All designed to control health care spending. So let's see. Drug spending is 11 percent of total health care dollars -- and is rising less rapidly than other expenditures -- and generic drug scrips are rising much more rapidly in every major chronic disease area. Yeah, criminalizing the private actions of MDs with respect to drug companies will really bring medical costs to a screeching halt.
I wonder what the conflict of interest police on the web think about that. Giddy with the thought of eager trial attorneys and regulatory agencies sticking it to Big Phrma...
And speaking of conflicts, which Sen. Murray made much of in introducing her bill, those who live in the Bay State might want to know that Murray is a key supporter of 40T which would allow people like her to appoint unelected special districts to take property and raise taxes for private development projects..
" Within the district, an appointed panel, handpicked by the developers, would replace many of the functions of elected municipal officials. They could raise taxes ("assessments") without regard to the constraints of Proposition 2 1/2. They could pass their own bylaws. A vote of their unelected panel would replace any requirement in Massachusetts law for a democratic vote of the people within the district. In effect, this bill creates new towns within towns in which democracy and public purpose are replaced by the rule of unelected officials with a profit motive.
Chapter 40T turns the concept of conflict of interest on its head because government powers would be blatantly exercised to enrich private parties. By evading democratic checks and balances, it offers unlimited opportunities for abuse."
http://www.masschc.org/chapter40T.html
No potential for conflict there.... I wonder who contributed to her campaign?
But watch the connect the dot crowd ignore the hypocrisy and double standards of the pols who want to put physicians on a watch list.
http://www.boston.com/news/local/articles/2008/03/04/ban_on_gifts_to_doctors_sought/
The conflict of interest movement is morphing into a lynch mob.. Read More & Comment...
03/04/2008 04:56 PM |
Senators Baucus and Conrad have introduced the “The Comparative Effectiveness Research Act of 2008â€. It has all of the conflicts and biases towards cost containment that other similar entities have.
1. It is a clone of the UK National Institute for Clinical Excellence (NICE) NICE is independent and does not mandate coverage, guidelines or reimbursement. SImilarly CERA does not mandate coverage, reimbursement, or other
policies for any public or private payer. States that none of the reports or research
findings shall be construed as mandates, guidelines, or policy recommendations.
But NICE winds up being the de fault position for National Health Service in the UK. In fact, after NICE was instituted, the NHS made acceptance of their evaluations a requirement for reimbursement. Nothing in the bill stops CMS or a private insurer from imposing that requirement on patients and doctors. But it will happen.
2. NICE completely ignores the development of metrics and measures to capture patient variation at the genetic and biological level in assessing value and outcomes.
So doe CERA. For all Baucus' observation that the age of personalized medicine and genetic engineering will
provide even more choices for patients and their physicians there is nothing -- absolutely nothing in the bill that would stimulate the development of measures and studies that reflect such advances. How can patients make choices among treatment options developed from personalized medicine with evaluation techniques that ignore such variation?
3. The bias towards large randomized trials, review of old and small studies and sponsors that benefit from it are grandfathered into CERA. The bill directs the Institute to "give preference to federal agencies and instrumentalities
with experience in conducting comparative effectiveness research, such as the
Agency for Healthcare Research and Quality (ARHQ), when entering into
contracts for the management and conduct of research according to the research
project agenda. "
Guess who ARHQ relies on for such research? Entities funded by HMOs and other payers with a goal towards cost containment. And it defers to the NIH which has given us CATIE, ALLHAT and the clarity-inducing results of the ACCORD study on the effect of reducing insulin below existing target levels on stroke and other diabetes related illness. Yes, money well spent. And it defers to CMS as well with it's well documented effort to develop patient-centered approaches to anemia drug dosing instead of a one size fits all approach...
Moreover, CERA "allows the Institute to alternatively enter into contracts with appropriate private sector research or study-conducting entities for the conduct of research according to the research project agenda."
Here's a hint, it's not Phrma or BIO or any of the study conducting entities they support. Of course neither. Not that either would be a better or less self-serving job.
4. CERA presumes that comparative effectiveness research does improve outcomes or improve better quality evidence concerning the best treatment, prevention, and management of the health conditions. It assumes that comparative effectiveness research helps patients, providers, and payers of health care to make more informed decisions.
Is there any evidence that these two assumptions are true?
How about a study to determine whether comparative effectiveness research is, compared to other types of research, actually achieves these goals? At least a meta-analysis or review to examine just how well-designed or comparatively effective comparative effectiveness research is...
And what if CERA becomes a de facto guideline for reimbursement and coverage. Doesn't it become another obstacle to access, just like in the UK, CMS and health plans that try to deny cancer patients coverage to innovative uses of new medicines?
How about a study about that?
All the "stakeholders" in DC and beyond are acting like this is a fait accompli. Hardly. By the time this bill gets through hearings and proper vetting, it will not stand in it's current form or at all. Read More & Comment...
1. It is a clone of the UK National Institute for Clinical Excellence (NICE) NICE is independent and does not mandate coverage, guidelines or reimbursement. SImilarly CERA does not mandate coverage, reimbursement, or other
policies for any public or private payer. States that none of the reports or research
findings shall be construed as mandates, guidelines, or policy recommendations.
But NICE winds up being the de fault position for National Health Service in the UK. In fact, after NICE was instituted, the NHS made acceptance of their evaluations a requirement for reimbursement. Nothing in the bill stops CMS or a private insurer from imposing that requirement on patients and doctors. But it will happen.
2. NICE completely ignores the development of metrics and measures to capture patient variation at the genetic and biological level in assessing value and outcomes.
So doe CERA. For all Baucus' observation that the age of personalized medicine and genetic engineering will
provide even more choices for patients and their physicians there is nothing -- absolutely nothing in the bill that would stimulate the development of measures and studies that reflect such advances. How can patients make choices among treatment options developed from personalized medicine with evaluation techniques that ignore such variation?
3. The bias towards large randomized trials, review of old and small studies and sponsors that benefit from it are grandfathered into CERA. The bill directs the Institute to "give preference to federal agencies and instrumentalities
with experience in conducting comparative effectiveness research, such as the
Agency for Healthcare Research and Quality (ARHQ), when entering into
contracts for the management and conduct of research according to the research
project agenda. "
Guess who ARHQ relies on for such research? Entities funded by HMOs and other payers with a goal towards cost containment. And it defers to the NIH which has given us CATIE, ALLHAT and the clarity-inducing results of the ACCORD study on the effect of reducing insulin below existing target levels on stroke and other diabetes related illness. Yes, money well spent. And it defers to CMS as well with it's well documented effort to develop patient-centered approaches to anemia drug dosing instead of a one size fits all approach...
Moreover, CERA "allows the Institute to alternatively enter into contracts with appropriate private sector research or study-conducting entities for the conduct of research according to the research project agenda."
Here's a hint, it's not Phrma or BIO or any of the study conducting entities they support. Of course neither. Not that either would be a better or less self-serving job.
4. CERA presumes that comparative effectiveness research does improve outcomes or improve better quality evidence concerning the best treatment, prevention, and management of the health conditions. It assumes that comparative effectiveness research helps patients, providers, and payers of health care to make more informed decisions.
Is there any evidence that these two assumptions are true?
How about a study to determine whether comparative effectiveness research is, compared to other types of research, actually achieves these goals? At least a meta-analysis or review to examine just how well-designed or comparatively effective comparative effectiveness research is...
And what if CERA becomes a de facto guideline for reimbursement and coverage. Doesn't it become another obstacle to access, just like in the UK, CMS and health plans that try to deny cancer patients coverage to innovative uses of new medicines?
How about a study about that?
All the "stakeholders" in DC and beyond are acting like this is a fait accompli. Hardly. By the time this bill gets through hearings and proper vetting, it will not stand in it's current form or at all. Read More & Comment...
03/04/2008 09:24 AM |
On the heels of my article discussing McCain's market-driven views on health comes his statement to the effect that credible scientists believe that vaccines cause autism.
I think McCain is misinformed and was responding to a question from a parent with autism who really believes in this crap.
If he clarifies on the basis of sound science it will be a one day story. If not, as the folks at http://overlawyered.com note, he will have stepped in it big time:
"The Republican candidate sticks his foot in it in a major way on a topic extensively covered here over the years (as well as at my other site). Writes Mark Kleiman: "the thimerosal-autism theory is as dead as phlogiston in respectable company. I'm not surprised that 'respectable company' excludes a few ambulance-chasing lawyers looking for deep pockets and a some emotionally devastated parents looking for someone to blame. But it's distressing — to use no stronger term — that the presumptive Republican nominee for President, rather than looking at the evidence, has chosen to side with the panic-spreaders and pander to the emotions of the panic victims."
My take. This was a well-meaning but less than informed statement. McCain is not the first Senator to know little about the complexities of this issue. Let's give the guy a couple of days to actually look at the evidence instead of being force fed foolishness from Dan Burton.
And PS. Autism cases have NOT increase as the Senator stated. Reclassification explains the surge in incidence and prevalence. Read More & Comment...
I think McCain is misinformed and was responding to a question from a parent with autism who really believes in this crap.
If he clarifies on the basis of sound science it will be a one day story. If not, as the folks at http://overlawyered.com note, he will have stepped in it big time:
"The Republican candidate sticks his foot in it in a major way on a topic extensively covered here over the years (as well as at my other site). Writes Mark Kleiman: "the thimerosal-autism theory is as dead as phlogiston in respectable company. I'm not surprised that 'respectable company' excludes a few ambulance-chasing lawyers looking for deep pockets and a some emotionally devastated parents looking for someone to blame. But it's distressing — to use no stronger term — that the presumptive Republican nominee for President, rather than looking at the evidence, has chosen to side with the panic-spreaders and pander to the emotions of the panic victims."
My take. This was a well-meaning but less than informed statement. McCain is not the first Senator to know little about the complexities of this issue. Let's give the guy a couple of days to actually look at the evidence instead of being force fed foolishness from Dan Burton.
And PS. Autism cases have NOT increase as the Senator stated. Reclassification explains the surge in incidence and prevalence. Read More & Comment...
03/04/2008 07:41 AM |
We strongly support the free and fair sharing of legitimate scientific information. That's why we're in favor of both the use of reprints as an important way to share cutting-edge medical information with physicians and the FDA's draft rule on the appropriate ways to do so.
That being said, some organizations (notably those who publish medical journals) aren't quite so clear as to what they believe. In fact there seems to be a lot of "do as I say not as I do" going on these days.
Speaking about how pharmaceutical companies use medical journal reprints, here's what Catherine DeAngelis, MD -- editor-in-chief of the Journal of the American Medical Association -- said in yesterday's edition of the Newark Star-Ledger:
"I am really upset they would use these articles instead of seeking FDA approval for a new use," she said. "It's easier for them to take a drug they already have and get people to use it for something for which it has not been approved than it is to conduct new clinical trials."
Could this be the same JAMA that has a glossy sales brochure on the value of reprints -- many of which discuss off-label studies?
Some verbatim verbiage from the JAMA sales aid:
"Designed to be turn-key for rep delivery, mail, and distribution at conventions"
"Stimulates physician"
"Serves as an innovative, new offering for sales representatives and as a meeting premium"
The JAMA brochure goes on to quote (anonymously) some of its satisfied customers:
"I use them as a sales tool and patient education material."
"My accounts are refreshed by this type of promotional item because it shows that we have a genuine interest in patient needs and education."
JAMA also quotes research showing the efficacy of such reprints:
"38% of physicians cite pharmaceutical sales representatives as the most frequent source of providing patient education materials."
There's no qualifier about what articles can be reprinted. No caveat against reprints that include discussions of off-label usage -- however there is a strict rule that the full FDA PI must be included in every reprint package.
Nor is JAMA taking aesthetics for granted. The covers of these reprint programs can be customized from a selection of 10 Alfons Van Cleven paintings. My favorite is "Fall Landscape in Deer Grove" -- although for a reprint on Lyme Disease, perhaps "Winter Sunset" would be more appropriate.
Helpfully, the JAMA brochure points out that Van Cleven is an artist from the school known as "New Realism."
Yeah, New Realism. It must be Dr. DeAngelis' favorite.
There's a lot of that going around these days. Read More & Comment...
That being said, some organizations (notably those who publish medical journals) aren't quite so clear as to what they believe. In fact there seems to be a lot of "do as I say not as I do" going on these days.
Speaking about how pharmaceutical companies use medical journal reprints, here's what Catherine DeAngelis, MD -- editor-in-chief of the Journal of the American Medical Association -- said in yesterday's edition of the Newark Star-Ledger:
"I am really upset they would use these articles instead of seeking FDA approval for a new use," she said. "It's easier for them to take a drug they already have and get people to use it for something for which it has not been approved than it is to conduct new clinical trials."
Could this be the same JAMA that has a glossy sales brochure on the value of reprints -- many of which discuss off-label studies?
Some verbatim verbiage from the JAMA sales aid:
"Designed to be turn-key for rep delivery, mail, and distribution at conventions"
"Stimulates physician"
"Serves as an innovative, new offering for sales representatives and as a meeting premium"
The JAMA brochure goes on to quote (anonymously) some of its satisfied customers:
"I use them as a sales tool and patient education material."
"My accounts are refreshed by this type of promotional item because it shows that we have a genuine interest in patient needs and education."
JAMA also quotes research showing the efficacy of such reprints:
"38% of physicians cite pharmaceutical sales representatives as the most frequent source of providing patient education materials."
There's no qualifier about what articles can be reprinted. No caveat against reprints that include discussions of off-label usage -- however there is a strict rule that the full FDA PI must be included in every reprint package.
Nor is JAMA taking aesthetics for granted. The covers of these reprint programs can be customized from a selection of 10 Alfons Van Cleven paintings. My favorite is "Fall Landscape in Deer Grove" -- although for a reprint on Lyme Disease, perhaps "Winter Sunset" would be more appropriate.
Helpfully, the JAMA brochure points out that Van Cleven is an artist from the school known as "New Realism."
Yeah, New Realism. It must be Dr. DeAngelis' favorite.
There's a lot of that going around these days. Read More & Comment...
03/03/2008 01:33 PM |
According to an article in the Connecticut Post:
"The federal government has a role in helping jump start the economy in the Naugatuck Valley, but much of that initiative needs to be done through a public/private partnership, U.S. Rep. Rosa DeLauro, D-3, told members of the Valley Chamber of Commerce this morning."
Representative DeLauro -- how about some support for another public/private partnership, one will help jump start 21st century health care -- the Reagan/Udall Foundation. Read More & Comment...
"The federal government has a role in helping jump start the economy in the Naugatuck Valley, but much of that initiative needs to be done through a public/private partnership, U.S. Rep. Rosa DeLauro, D-3, told members of the Valley Chamber of Commerce this morning."
Representative DeLauro -- how about some support for another public/private partnership, one will help jump start 21st century health care -- the Reagan/Udall Foundation. Read More & Comment...
03/03/2008 12:30 PM |
Previously we commented on the WHO sending a team to Bangkok to discuss compulsory licensing in the broader context of TRIPS flexibiltiies ("WHO to WIPO: Having wonderful time. Glad you're not here").
Here's a link to those comments:
http://drugwonks.com/2008/02/who_to_wipo_having_wonderful_time_glad_youre_not_here.html
Well, the WHO has completed it's report -- and it's a doozy. Here's a link to the complete report:
Download file
To give you a hint as to the direction of the study, here are the final 14 words of the report:
"WHO supports measures which improve access to essential medicines, including application of TRIPS flexibilities."
And in the context of the report, "TRIPS flexibilities" means "compulsory licensing."
However, earlier in the report, the WHO team has a moment of cognitive lucidity. Consider this statement:
"A competitive marketplace is the best way to ensure low prices for medicines. Proper organization of the market and application of anti-trust (monopoly) laws should facilitate price competition."
But it's only a brief shining moment. Here's the end of that paragraph:
"However, if the pharmaceutical market is not competitive and/or there is a need to contain medicine prices, governments may choose to institute price controls."
This report is both a "how-to" guide for nations considering compulsory licensing and a WHO-ized papal dispensation for intellectual property theft.
What would John Calvin say? Read More & Comment...
Here's a link to those comments:
http://drugwonks.com/2008/02/who_to_wipo_having_wonderful_time_glad_youre_not_here.html
Well, the WHO has completed it's report -- and it's a doozy. Here's a link to the complete report:
Download file
To give you a hint as to the direction of the study, here are the final 14 words of the report:
"WHO supports measures which improve access to essential medicines, including application of TRIPS flexibilities."
And in the context of the report, "TRIPS flexibilities" means "compulsory licensing."
However, earlier in the report, the WHO team has a moment of cognitive lucidity. Consider this statement:
"A competitive marketplace is the best way to ensure low prices for medicines. Proper organization of the market and application of anti-trust (monopoly) laws should facilitate price competition."
But it's only a brief shining moment. Here's the end of that paragraph:
"However, if the pharmaceutical market is not competitive and/or there is a need to contain medicine prices, governments may choose to institute price controls."
This report is both a "how-to" guide for nations considering compulsory licensing and a WHO-ized papal dispensation for intellectual property theft.
What would John Calvin say? Read More & Comment...
03/03/2008 12:13 PM |
According to a report in the International Herald Tribune (via the Associated Press), the recently appointed head of Thailand's Food and Drug Administration resigned Monday "amid controversy over the new government's plan to review a policy of overriding patents on several expensive cancer-fighting drugs."
Chatree Banchuen was named secretary general of the FDA last week, making him the government's chief negotiator with multinational drug companies over pricing and licensing terms.
Chatree said he decided to resign because he felt "uncomfortable with the politics," explaining that critics had brought up old, unproven allegations linking him to corruption in a computer procurement project in 2003. He called the allegations "politically motivated and
groundless," without elaborating.
Here's a link to the complete article:
http://www.iht.com/articles/ap/2008/03/03/asia/AS-GEN-Thailand-Drug-Patents.php
Whether it's "questionable" purchasing practices for computers or prescription medicines it all equals the same thing -- theft. Read More & Comment...
Chatree Banchuen was named secretary general of the FDA last week, making him the government's chief negotiator with multinational drug companies over pricing and licensing terms.
Chatree said he decided to resign because he felt "uncomfortable with the politics," explaining that critics had brought up old, unproven allegations linking him to corruption in a computer procurement project in 2003. He called the allegations "politically motivated and
groundless," without elaborating.
Here's a link to the complete article:
http://www.iht.com/articles/ap/2008/03/03/asia/AS-GEN-Thailand-Drug-Patents.php
Whether it's "questionable" purchasing practices for computers or prescription medicines it all equals the same thing -- theft. Read More & Comment...
03/03/2008 11:26 AM |
Although HTAs seem not to have hit my home country yet, because of socialized medicine this appears generally without giving its name.
Recently, the head doctor and chief of oncology at the university hospital of Lund (south Sweden) caught headlines by stating that he had changed his mind about approving new cancer medicines, as results kept improving due to these new treatments. In this week’s issue of Dagens Medicin (a Swedish weekly for health care, www.dagensmedicin.se), he restates the budgetary implications of having recourse to the latest treatments : "If a new medicine with a proven impact on the current pathology exists, then most patients (…) will demand it, regardless of the therapeutic effect."
Indeed : so would most patients, and so would Dr. Rose. His concern is budgetary, both as head of a clinic and as a professional. And his reversed position is very positive ; but saying that, since the number of new treatments in oncology is increasing radically, the "equation is insoluble" mainly reflects that the concerns of socialized medicine (as is unfortunately the dominating feature in Sweden) carry greater weight than the number of patients cured.
This article from the Journal of Clinical Oncology (http://jco.ascopubs.org/cgi/content/full/26/1/6) reviews the most prominent results over the past 25 years. And Dr. Rose’s conclusion, after going through these is the right one : « This (…) makes it virtually medically undefendable not to treat patients with primary liver cancer or metastasizing kidney cell cancers. But in Sweden there is currently no connection between a possible treatment effect of new and costly medicines and the budgetary requirements of the concerned clinics. »
The defence rests. Read More & Comment...
Recently, the head doctor and chief of oncology at the university hospital of Lund (south Sweden) caught headlines by stating that he had changed his mind about approving new cancer medicines, as results kept improving due to these new treatments. In this week’s issue of Dagens Medicin (a Swedish weekly for health care, www.dagensmedicin.se), he restates the budgetary implications of having recourse to the latest treatments : "If a new medicine with a proven impact on the current pathology exists, then most patients (…) will demand it, regardless of the therapeutic effect."
Indeed : so would most patients, and so would Dr. Rose. His concern is budgetary, both as head of a clinic and as a professional. And his reversed position is very positive ; but saying that, since the number of new treatments in oncology is increasing radically, the "equation is insoluble" mainly reflects that the concerns of socialized medicine (as is unfortunately the dominating feature in Sweden) carry greater weight than the number of patients cured.
This article from the Journal of Clinical Oncology (http://jco.ascopubs.org/cgi/content/full/26/1/6) reviews the most prominent results over the past 25 years. And Dr. Rose’s conclusion, after going through these is the right one : « This (…) makes it virtually medically undefendable not to treat patients with primary liver cancer or metastasizing kidney cell cancers. But in Sweden there is currently no connection between a possible treatment effect of new and costly medicines and the budgetary requirements of the concerned clinics. »
The defence rests. Read More & Comment...
03/03/2008 09:56 AM |
The Weekly Standard
The Real Reformer
McCain's superior prescription for health care.
by Robert Goldberg
03/10/2008, Volume 013, Issue 25
http://www.weeklystandard.com/Content/Public/Articles/000/000/014/818zqeqa.asp
John McCain's proposal for health care reform is more than a plan for making health care more affordable and for controlling costs through deregulation and market competition. It is also an attempt to restore independence and human dignity to patients. Both of his potential opponents in the fall presidential race speak only of extending the government's role in health care--a position supported in the main by large corporations, unions, and the managed-care lobbies. McCain's patient-centered position makes him--not Clinton or Obama--the force for change in health care.
McCain's plan is based around patient-centered initiatives that already have broad support among Republicans in Congress. They include letting people buy health insurance nationally instead of only from state-regulated firms; giving people the choice of purchasing coverage through cooperatives or other organizations (churches or civic groups, for example); expanding health savings accounts; and making health insurance portable by giving people tax credits of up to $5,000 per family to buy their own coverage instead of getting it through an employer.
His chief concern is for people to take ownership of their health care. McCain likes to note that "Ronald Reagan said nobody ever washed a rental car. And that's true in health insurance. If they're responsible for it, then they will take more care of it."
At the heart of McCain's proposals is his effort to allow veterans, particularly soldiers returning from Iraq with traumatic brain injury and mental illness, to get care anywhere rather than just through the Veterans Health Administration (VA): "America's veterans have fought for our freedom. We should give them freedom to choose to carry their VA dollars to a provider that gives them the timely care at high quality and in the best location."
What stirs McCain are stories like that of Sergeant Eric Edmundson who returned from Iraq unable to walk or talk after being hit by a roadside bomb. Edmundson was sent to a VA hospital in Richmond, Virginia, for rehabilitation care. After six months, doctors said he was in a permanent vegetative state and tried to send him to a nursing home where he would be discharged from the Army. But Edmundson's father found out that his son could use his GI vocational benefits (available only after he received VA care but also only if he remained in the service) to receive treatment at one of the world's leading traumatic brain injury (TBI) centers: the Rehabilitation Institute in Chicago. His father prevailed over VA objections. After six months of therapy at the Chicago center, Edmundson was able to talk and walked out of the rehab center under his own power.
The VA system that McCain is attacking is the starting point for the Democratic plans for universal health care. Both Hillary Clinton and Barack Obama want to expand the VA's electronic health care system to the rest of the country. Obama has promised to spend $50 billion on electronic health records based on the VA model. And Clinton likes to claim credit for that model, which she calls an astounding success:
We started during the Clinton administration to transition the VA system to a paperless system. .  .  . The VA is leading the way in reducing medical errors, improving patient safety, and delivering high quality care; now this is a lesson about what can be done when we have a plan. A plan that is evidence-based, a plan that uses what we know works, and a system that we can actually get to respond to that evidence-based planning.
In fact, as a government audit discovered, the VA's paperless system has created a huge bottleneck, losing track of 53,000 veterans.
Last year, Obama introduced legislation requiring the VA to treat each returning vet in 30 days. Yet, the VA already had such a requirement, and, according to internal VA audits, 25 percent of all vets wait more than 30 days for their first exam. Of the veterans kept waiting, 27 percent had serious service-connected disabilities, including amputations and chronic problems such as frequent panic attacks. Iraq war vets often have to wait six months for their first appointment.
In some VA hospitals, vets wait 18 months for surgeries--a record worse than Canada's or England's national health care systems. The VA's budget for its health care system has doubled since 2001, and Obama still proposes to give more money.
The differences between McCain and the Democratic candidates on health care boil down to freedom of choice. Clinton and Obama want in varying degrees to force Americans to enroll in health plans designed by the government and pay premiums set by the government. Companies that don't cover workers would be required to pay an additional tax to subsidize what amounts to Medicaid for all. If previous experience with S-chip is a guide, it will lead private firms to dump employees into government-run plans. Both Obama and Clinton would limit what drugs and services plans pay for to what the government deems "cost effective."
If you don't want government health care, you won't be able to set up a health savings account as they will be illegal. McCain would increase the opportunities for individuals to choose the care that's best for them by giving patients and doctors the dollars, information, and freedom to make medical decisions instead of a government agency.
Indeed, if Eric Edmundson's father had possessed the freedom to take his son to the best place for care instead of waiting for a bureaucrat's approval, his son would have been walking sooner. McCain's health care plan reflects his desire to make the medical system for vets embody the same freedom and dignity they fought for in Iraq. That's a powerful vision for reforming the whole health care system.
Robert Goldberg is the vice president of the Center for Medicine in the Public Interest.
© Copyright 2008, News Corporation, Weekly Standard, All Rights Reserved. Read More & Comment...
The Real Reformer
McCain's superior prescription for health care.
by Robert Goldberg
03/10/2008, Volume 013, Issue 25
http://www.weeklystandard.com/Content/Public/Articles/000/000/014/818zqeqa.asp
John McCain's proposal for health care reform is more than a plan for making health care more affordable and for controlling costs through deregulation and market competition. It is also an attempt to restore independence and human dignity to patients. Both of his potential opponents in the fall presidential race speak only of extending the government's role in health care--a position supported in the main by large corporations, unions, and the managed-care lobbies. McCain's patient-centered position makes him--not Clinton or Obama--the force for change in health care.
McCain's plan is based around patient-centered initiatives that already have broad support among Republicans in Congress. They include letting people buy health insurance nationally instead of only from state-regulated firms; giving people the choice of purchasing coverage through cooperatives or other organizations (churches or civic groups, for example); expanding health savings accounts; and making health insurance portable by giving people tax credits of up to $5,000 per family to buy their own coverage instead of getting it through an employer.
His chief concern is for people to take ownership of their health care. McCain likes to note that "Ronald Reagan said nobody ever washed a rental car. And that's true in health insurance. If they're responsible for it, then they will take more care of it."
At the heart of McCain's proposals is his effort to allow veterans, particularly soldiers returning from Iraq with traumatic brain injury and mental illness, to get care anywhere rather than just through the Veterans Health Administration (VA): "America's veterans have fought for our freedom. We should give them freedom to choose to carry their VA dollars to a provider that gives them the timely care at high quality and in the best location."
What stirs McCain are stories like that of Sergeant Eric Edmundson who returned from Iraq unable to walk or talk after being hit by a roadside bomb. Edmundson was sent to a VA hospital in Richmond, Virginia, for rehabilitation care. After six months, doctors said he was in a permanent vegetative state and tried to send him to a nursing home where he would be discharged from the Army. But Edmundson's father found out that his son could use his GI vocational benefits (available only after he received VA care but also only if he remained in the service) to receive treatment at one of the world's leading traumatic brain injury (TBI) centers: the Rehabilitation Institute in Chicago. His father prevailed over VA objections. After six months of therapy at the Chicago center, Edmundson was able to talk and walked out of the rehab center under his own power.
The VA system that McCain is attacking is the starting point for the Democratic plans for universal health care. Both Hillary Clinton and Barack Obama want to expand the VA's electronic health care system to the rest of the country. Obama has promised to spend $50 billion on electronic health records based on the VA model. And Clinton likes to claim credit for that model, which she calls an astounding success:
We started during the Clinton administration to transition the VA system to a paperless system. .  .  . The VA is leading the way in reducing medical errors, improving patient safety, and delivering high quality care; now this is a lesson about what can be done when we have a plan. A plan that is evidence-based, a plan that uses what we know works, and a system that we can actually get to respond to that evidence-based planning.
In fact, as a government audit discovered, the VA's paperless system has created a huge bottleneck, losing track of 53,000 veterans.
Last year, Obama introduced legislation requiring the VA to treat each returning vet in 30 days. Yet, the VA already had such a requirement, and, according to internal VA audits, 25 percent of all vets wait more than 30 days for their first exam. Of the veterans kept waiting, 27 percent had serious service-connected disabilities, including amputations and chronic problems such as frequent panic attacks. Iraq war vets often have to wait six months for their first appointment.
In some VA hospitals, vets wait 18 months for surgeries--a record worse than Canada's or England's national health care systems. The VA's budget for its health care system has doubled since 2001, and Obama still proposes to give more money.
The differences between McCain and the Democratic candidates on health care boil down to freedom of choice. Clinton and Obama want in varying degrees to force Americans to enroll in health plans designed by the government and pay premiums set by the government. Companies that don't cover workers would be required to pay an additional tax to subsidize what amounts to Medicaid for all. If previous experience with S-chip is a guide, it will lead private firms to dump employees into government-run plans. Both Obama and Clinton would limit what drugs and services plans pay for to what the government deems "cost effective."
If you don't want government health care, you won't be able to set up a health savings account as they will be illegal. McCain would increase the opportunities for individuals to choose the care that's best for them by giving patients and doctors the dollars, information, and freedom to make medical decisions instead of a government agency.
Indeed, if Eric Edmundson's father had possessed the freedom to take his son to the best place for care instead of waiting for a bureaucrat's approval, his son would have been walking sooner. McCain's health care plan reflects his desire to make the medical system for vets embody the same freedom and dignity they fought for in Iraq. That's a powerful vision for reforming the whole health care system.
Robert Goldberg is the vice president of the Center for Medicine in the Public Interest.
© Copyright 2008, News Corporation, Weekly Standard, All Rights Reserved. Read More & Comment...
03/03/2008 07:59 AM |
Here is the second installment from our recent health care leadership forum on patient-centric medicine. These are the comments of Ralph Snyderman, M.D., recipient of the 2007 Leadership in Personalized Medicine Award from the Personalized Medicine Coalition.
Dr. Snyderman is Chancellor Emeritus at Duke University and former Chancellor for Health Affairs at Duke University, President and CEO of Duke University Health System and James B. Duke Professor of Medicine. He oversaw the development of the Duke University Health System, one of the few fully integrated academic health systems in the country. This integrated health system now provides an increasing continuum of care throughout North Carolina and beyond. Dr. Snyderman describes how the current health system is broken and how patient centric medicine could help repair it.
"We all recognize that the current healthcare system is broken. We’re spending $2.2 trillion a year, not on a healthcare system but a sick-care system that is highly inefficient.
Seventy-five cents of every healthcare dollar is spent for the acute treatment of generally late-stage chronic disease, which is often preventable.
The patient, of course, is in a quandary. I only know of two industries in which the consumer is given so little attention. One is the airline industry, which pretty much doesn’t care about the consumer. And, ironically, the healthcare system. The consumer is in there, but always as byproduct of all the technologies, the capabilities, that are being developed.
The likelihood of an individual developing a chronic disease is based on a number of things. Number one is their baseline inherited risk. That’s then modified by environmental or initiating events, exposure to things or various behaviors which may lead to preclinical progression, disease initiation. All of this develops over time, most often many years.
The irony is that as you wait, there tends to be an accumulation of disease burden. Once it becomes clinically manifest, and then there tends to be an inflection, a crescendo, in which things can get steadily worse in a series of acute events. Our current healthcare system is designed to focus on acute events. That’s where the cost is high and reversibility is low because there was a buildup of pathology.
Now the good news is that now we have powerful emerging technologies that are very producing powerful, and we’re developing important therapeutics, plus important diagnostics, including those that will enable personal clinical risk prediction,. Genomics, proteomics, metabolomics, new medical technologies, informatics and system biology, which is an approach to understanding the multiple networks of genes and metabolic systems, can all have a positive impact in empowering personalized health risk assessment..
We need to communicate that the power of these new technologies is allowing us to develop the capabilities of predicting risk in a much shorter time-frame and actually being able to predict risk across a person’s life. That’s a whole different approach to health care -- individualized risk prediction.
We’ll be able to measure what’s actually going on in a person’s circulation and tissues to determine if they are progressing along a disease pathway. It’s fairly clear that with risk prediction tools along with powerful digital imaging, metabolic imaging and other technologies, we can start to determine disease initiation and progression. We are going to get so much better with in being able to track development of problems very early on. Individuals are different. And where somebody might benefit from a thiazide diuretic, somebody else may be very badly harmed. We cannot assume that everybody will benefit from the same approaches or therapies.
We are beginning to understand that severe adverse outcomes can be predictable on a personalized basis, and the benefits of various therapies could be predicted at a personalized level.
A number of companies have sprung up to try to develop predictive tools for disease events, to personalize therapy. By studying a population of patients and outcomes, you can try to determine what individual factors helped predicted determine the outcome. Whether they be clinical data, genetic data, proteomic data, any other digital kind of information can be analyzed in clinical cohorts with the use of various types of biostatistical algorithms to come up with a predictive model. The power of these models is going to get better as we have more precise clinical data.
There is an emerging movement, what some people call P-4 Medicine or what I call prospective health care—personalized, predictive, preventative, and participatory. It would be personalized to the individual; predictive, so we could anticipate events before they occur, and then try to prevent them. The patient’s participation is a key feature. It’s hard to imagine a fix until we build this in, that people get invested in being more responsible for their own health.
For prospective healthcare to create an individual strategic health plan to for each patient, we need to develop these risk assessment and therapeutic evaluation tools. How is health care itself delivered to an individual over time? Our delivery system is designed for acute intervention that is not integrated and doesn’t provide continuity of care. The reimbursement system has a lot to do with that. Institutions can lose a lot of money trying to do the right thing in providing continuity of care.
At Duke, we have a prospective healthcare program where the participating population is university employees who get their care from Duke. They Duke is are essentially self-insured, so it’s one of those areas in which the reimbursement systems actually align. We have employees who stay with us very often for their entire professional lives. With the right tools, you can then, based on the chronic disease, divide the population into those that are low risk, high risk, early chronic disease, late chronic disease, and align the resources to the needs of the individual patient. So that in those individuals who may be high risk are given, we give them a lot of help in terms of risk modification, and allow helped them to develop their own strategic health plans. The general concept is to divide the population based on their specific risks and their health status and then give them access to the level of support they need.
The individual needs to play an active different role. We need to do something to raise the attention of the public of health as a value. One of the things that amuses me seems to be that over the last three to six months, virtually every major industry that contributes to environmental pollution has become green. Every oil company is green. General Motors is green. Everything is green to try to save the planet. Well, what about health? What about the individual? We talk about a sustainable planet, but what about a sustainable individual? We really need to get the appreciation of health as a value, similar to what we’re doing with the planet as a value." Read More & Comment...
Dr. Snyderman is Chancellor Emeritus at Duke University and former Chancellor for Health Affairs at Duke University, President and CEO of Duke University Health System and James B. Duke Professor of Medicine. He oversaw the development of the Duke University Health System, one of the few fully integrated academic health systems in the country. This integrated health system now provides an increasing continuum of care throughout North Carolina and beyond. Dr. Snyderman describes how the current health system is broken and how patient centric medicine could help repair it.
"We all recognize that the current healthcare system is broken. We’re spending $2.2 trillion a year, not on a healthcare system but a sick-care system that is highly inefficient.
Seventy-five cents of every healthcare dollar is spent for the acute treatment of generally late-stage chronic disease, which is often preventable.
The patient, of course, is in a quandary. I only know of two industries in which the consumer is given so little attention. One is the airline industry, which pretty much doesn’t care about the consumer. And, ironically, the healthcare system. The consumer is in there, but always as byproduct of all the technologies, the capabilities, that are being developed.
The likelihood of an individual developing a chronic disease is based on a number of things. Number one is their baseline inherited risk. That’s then modified by environmental or initiating events, exposure to things or various behaviors which may lead to preclinical progression, disease initiation. All of this develops over time, most often many years.
The irony is that as you wait, there tends to be an accumulation of disease burden. Once it becomes clinically manifest, and then there tends to be an inflection, a crescendo, in which things can get steadily worse in a series of acute events. Our current healthcare system is designed to focus on acute events. That’s where the cost is high and reversibility is low because there was a buildup of pathology.
Now the good news is that now we have powerful emerging technologies that are very producing powerful, and we’re developing important therapeutics, plus important diagnostics, including those that will enable personal clinical risk prediction,. Genomics, proteomics, metabolomics, new medical technologies, informatics and system biology, which is an approach to understanding the multiple networks of genes and metabolic systems, can all have a positive impact in empowering personalized health risk assessment..
We need to communicate that the power of these new technologies is allowing us to develop the capabilities of predicting risk in a much shorter time-frame and actually being able to predict risk across a person’s life. That’s a whole different approach to health care -- individualized risk prediction.
We’ll be able to measure what’s actually going on in a person’s circulation and tissues to determine if they are progressing along a disease pathway. It’s fairly clear that with risk prediction tools along with powerful digital imaging, metabolic imaging and other technologies, we can start to determine disease initiation and progression. We are going to get so much better with in being able to track development of problems very early on. Individuals are different. And where somebody might benefit from a thiazide diuretic, somebody else may be very badly harmed. We cannot assume that everybody will benefit from the same approaches or therapies.
We are beginning to understand that severe adverse outcomes can be predictable on a personalized basis, and the benefits of various therapies could be predicted at a personalized level.
A number of companies have sprung up to try to develop predictive tools for disease events, to personalize therapy. By studying a population of patients and outcomes, you can try to determine what individual factors helped predicted determine the outcome. Whether they be clinical data, genetic data, proteomic data, any other digital kind of information can be analyzed in clinical cohorts with the use of various types of biostatistical algorithms to come up with a predictive model. The power of these models is going to get better as we have more precise clinical data.
There is an emerging movement, what some people call P-4 Medicine or what I call prospective health care—personalized, predictive, preventative, and participatory. It would be personalized to the individual; predictive, so we could anticipate events before they occur, and then try to prevent them. The patient’s participation is a key feature. It’s hard to imagine a fix until we build this in, that people get invested in being more responsible for their own health.
For prospective healthcare to create an individual strategic health plan to for each patient, we need to develop these risk assessment and therapeutic evaluation tools. How is health care itself delivered to an individual over time? Our delivery system is designed for acute intervention that is not integrated and doesn’t provide continuity of care. The reimbursement system has a lot to do with that. Institutions can lose a lot of money trying to do the right thing in providing continuity of care.
At Duke, we have a prospective healthcare program where the participating population is university employees who get their care from Duke. They Duke is are essentially self-insured, so it’s one of those areas in which the reimbursement systems actually align. We have employees who stay with us very often for their entire professional lives. With the right tools, you can then, based on the chronic disease, divide the population into those that are low risk, high risk, early chronic disease, late chronic disease, and align the resources to the needs of the individual patient. So that in those individuals who may be high risk are given, we give them a lot of help in terms of risk modification, and allow helped them to develop their own strategic health plans. The general concept is to divide the population based on their specific risks and their health status and then give them access to the level of support they need.
The individual needs to play an active different role. We need to do something to raise the attention of the public of health as a value. One of the things that amuses me seems to be that over the last three to six months, virtually every major industry that contributes to environmental pollution has become green. Every oil company is green. General Motors is green. Everything is green to try to save the planet. Well, what about health? What about the individual? We talk about a sustainable planet, but what about a sustainable individual? We really need to get the appreciation of health as a value, similar to what we’re doing with the planet as a value." Read More & Comment...
02/29/2008 11:05 AM |
I received a nice 20 page glossy report from Blue Cross Blue Shield Association entitled:
"The Pathway to Covering America:Ensuring Quality, Value and Access." Let's set aside the image of a pathway covering something (isn't that a bit convoluted?) and the semi-fictitious factoids about health care (people without coverage get sicker and die sooner than those with coverage, sort of true but not always so for many, many reasons).
The heart of the proposal is the claim that "America needs an independent institute to support research comparing the relative effectiveness of new and existing medical procedures, drugs, devices and biologics" and that "Medicare and other public program should be required to consider the Institute's research in developing pay for performance, coverage, reimbursement and other policies."
So social scientists culling through research -- using meta- analysis mostly -- will create practice guidelines that will dictate to doctors and patients what care they will receive. All paid for by a tax on our premiums.
BCBS says that the Institute should contract with existing entities to facilitate research and collaborate with "institutes that receive comparative research contracts to identify best practices...in order to maximize research dollars."
Guess who has an "existing" entity?
BCBS. In the form of a Technology Evaluation Center. And it is already "one of the 14 Evidence-Based Practice Center for the US Agency for Healthcare Research and Quality. It also provides evaluations to Medicare and Medicaid. BCBS says: " TEC Assessments should not be construed to suggest that the Blue Cross Blue Shield Association, Kaiser Permanente Medical Care Program or the TEC Program recommends, advocates, requires, encourages, or discourages any particular treatment, procedure, or service; any particular course of treatment, procedure, or service; or the payment or non-payment of the technology or technologies evaluated."
Of course not! Who would think such a thing! But imagine if Phrma or BIO instead of BCBS or Kaiser were running a TEC that in turn would be part and parcel of the Comparative Effectiveness Institute right off the bat. The screams about conflict would be heard round the world.
Meanwhile, here's a flavor of how slow-footed and lethal TEC transfer can be.
The munchkins at TEC central went on and on about how there was, for off-label indications of sunitinib or Nexavar (hepatocellular carcinoma), no studies were found that met selection criteria for this assessment (Who died and made them king?) That included use for renal cell carcinoma. So in otherwords the progression free survival of patients on Nexavar reported in the NEJM means nothing, as does the reports of efficacy in several other studies. (See Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34.) But of course " assessments should not be construed to suggest that the Blue Cross Blue Shield Association, Kaiser Permanente Medical Care Program or the TEC Program recommends, advocates, requires, encourages, or discourages any particular treatment, procedure, or service; any particular course of treatment, procedure, or service; or the payment or non-payment of the technology or technologies evaluated."
Of course not. We will leave that to the national Comparative Effectiveness Board which will collaborate with TEC to maximize research dollars.
Let's see Healthcare Renewal and the other conflict of interest police defend this one. Letting people die to save dollars... Read More & Comment...
"The Pathway to Covering America:Ensuring Quality, Value and Access." Let's set aside the image of a pathway covering something (isn't that a bit convoluted?) and the semi-fictitious factoids about health care (people without coverage get sicker and die sooner than those with coverage, sort of true but not always so for many, many reasons).
The heart of the proposal is the claim that "America needs an independent institute to support research comparing the relative effectiveness of new and existing medical procedures, drugs, devices and biologics" and that "Medicare and other public program should be required to consider the Institute's research in developing pay for performance, coverage, reimbursement and other policies."
So social scientists culling through research -- using meta- analysis mostly -- will create practice guidelines that will dictate to doctors and patients what care they will receive. All paid for by a tax on our premiums.
BCBS says that the Institute should contract with existing entities to facilitate research and collaborate with "institutes that receive comparative research contracts to identify best practices...in order to maximize research dollars."
Guess who has an "existing" entity?
BCBS. In the form of a Technology Evaluation Center. And it is already "one of the 14 Evidence-Based Practice Center for the US Agency for Healthcare Research and Quality. It also provides evaluations to Medicare and Medicaid. BCBS says: " TEC Assessments should not be construed to suggest that the Blue Cross Blue Shield Association, Kaiser Permanente Medical Care Program or the TEC Program recommends, advocates, requires, encourages, or discourages any particular treatment, procedure, or service; any particular course of treatment, procedure, or service; or the payment or non-payment of the technology or technologies evaluated."
Of course not! Who would think such a thing! But imagine if Phrma or BIO instead of BCBS or Kaiser were running a TEC that in turn would be part and parcel of the Comparative Effectiveness Institute right off the bat. The screams about conflict would be heard round the world.
Meanwhile, here's a flavor of how slow-footed and lethal TEC transfer can be.
The munchkins at TEC central went on and on about how there was, for off-label indications of sunitinib or Nexavar (hepatocellular carcinoma), no studies were found that met selection criteria for this assessment (Who died and made them king?) That included use for renal cell carcinoma. So in otherwords the progression free survival of patients on Nexavar reported in the NEJM means nothing, as does the reports of efficacy in several other studies. (See Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34.) But of course " assessments should not be construed to suggest that the Blue Cross Blue Shield Association, Kaiser Permanente Medical Care Program or the TEC Program recommends, advocates, requires, encourages, or discourages any particular treatment, procedure, or service; any particular course of treatment, procedure, or service; or the payment or non-payment of the technology or technologies evaluated."
Of course not. We will leave that to the national Comparative Effectiveness Board which will collaborate with TEC to maximize research dollars.
Let's see Healthcare Renewal and the other conflict of interest police defend this one. Letting people die to save dollars... Read More & Comment...
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