Latest Drugwonks' Blog
The Reagan-Udall Foundation was created to promote new tools to accelerate the development a new generation of targeted medicines. The emphasis is on tools, meaning biomarkers, meaning coming up with validated measures and standards at a time when we have a lot of data and information but very little knowledge.
I hope the Foundation focuses on very mundane and important scientific work and provides hub for achieving consensus on measures and markers for qualifying and ap approving drugs based on actual biological differences and mechanisms. And I hope pharma does begin to more money into credible scientific projects that will help change the regulatory paradigm. The scientists in the companies want to do the right thing. I am not always so sure of the marketing types who still cling to the one size fits all blockbuster mentality and who have not yet realized that if drug companies don't get into the business of tracking the safety of their drugs in the post market -- using these tools in research and clinical settings -- they will continue to get clubbed by the likes of Nissen and Graham. If they don't seize the opportunity given to them in Reagan Udall then well....it's their own fault.
Of course, the fact that this might make drug development more efficient years from now (i.e. fewer clinical trials, more subpopulations targeted) and might help drug companies will drive the Marcia Angells, Kassirers, Avorns, etc crazy. Matt Perrone has an excellent piece that captures the knee-jerk "corporations are evil" bleating from the likes of The Union of Conceited Scientists.
Matt Perrone ought to brush up on what a biomarker is however otherwise he will continue to be misled by likes of David Ross who gave him this example:
"For example, Ross, who left the FDA last year over a drug safety dispute, is concerned, as are others, that the FDA might be persuaded to quickly adopt a controversial drug-testing process that uses biological indicators, such as blood pressure and cholesterol levels, to determine a drug's safety.
Drug companies have taken the unusual step of sharing research data on these indicators, called biomarkers, to see if the size and duration of patient drug trails can be reduced. Some critics call their use a high-risk gamble.
"Biomarkers are a bit like dynamite in that they can be extremely useful but they can cause a lot of damage," said Ross.
He cites a biomarker that suggested irregular heart rhythms were a key predictor of fatal heart attacks. Using the assumption, doctors prescribed heart-regulating drugs to millions of patients in the 1980s but abruptly halted the practice in 1989 when a long-term study revealed patients were actually more than twice as likely to die of sudden heart failure."
Note to Perrone and Ross: The reason people died was because the drug was prescribed to patients outside of the clinical trial guideline. Ross is using the "generic" definition of a biomarker, meaning biological measure that is linked to a disease state. A biomarker that captured genetic variations explaining why people more likely to die from the drug is now possible to develop using a blood test. I guess we shouldn't use that. Ditto, all those tests that can now screen to see which people respond to certain cancer drugs and avoid needless chemotherapy or which HIV drugs will work for them.
It should also be noted that Ross was one of the biggest loudmouths about the dangers of SSRIs which have been overhyped to the point that prescriptions are down and suicides are up.
This effort to eliminate measures like cholesterol, glycemic index, bone density, blood pressure as conditions of approval is just an effort to slow down drug approval and move it into the dark ages. It is being engineered by those who believe that the current approach to clinical evaluation is corrupt and corporatized. Supporters offer this more rigid and unreachable methods not because they are based on better science but because they reduce the number of new medicines that companies develop. The attack is political, pure and simple.
The battle lines are already being defined: The opponents of the Foundation and Critical Path oppose both because it might advance industry and industry is evil. (Even though most of the research will be done in collaboration with academia and NIH). Because corporations are involved it is inherently evil and corrupt. WHich allow the other side to distort the mission and the science all they want.
The headline in the WP "New FDA Research Center Rife WIth Risks" tells you that Reagan Udall has already been spun. How sick and sad is that?
http://www.washingtonpost.com/wp-dyn/content/article/2007/10/14/AR2007101400722.html
I hope the Foundation focuses on very mundane and important scientific work and provides hub for achieving consensus on measures and markers for qualifying and ap approving drugs based on actual biological differences and mechanisms. And I hope pharma does begin to more money into credible scientific projects that will help change the regulatory paradigm. The scientists in the companies want to do the right thing. I am not always so sure of the marketing types who still cling to the one size fits all blockbuster mentality and who have not yet realized that if drug companies don't get into the business of tracking the safety of their drugs in the post market -- using these tools in research and clinical settings -- they will continue to get clubbed by the likes of Nissen and Graham. If they don't seize the opportunity given to them in Reagan Udall then well....it's their own fault.
Of course, the fact that this might make drug development more efficient years from now (i.e. fewer clinical trials, more subpopulations targeted) and might help drug companies will drive the Marcia Angells, Kassirers, Avorns, etc crazy. Matt Perrone has an excellent piece that captures the knee-jerk "corporations are evil" bleating from the likes of The Union of Conceited Scientists.
Matt Perrone ought to brush up on what a biomarker is however otherwise he will continue to be misled by likes of David Ross who gave him this example:
"For example, Ross, who left the FDA last year over a drug safety dispute, is concerned, as are others, that the FDA might be persuaded to quickly adopt a controversial drug-testing process that uses biological indicators, such as blood pressure and cholesterol levels, to determine a drug's safety.
Drug companies have taken the unusual step of sharing research data on these indicators, called biomarkers, to see if the size and duration of patient drug trails can be reduced. Some critics call their use a high-risk gamble.
"Biomarkers are a bit like dynamite in that they can be extremely useful but they can cause a lot of damage," said Ross.
He cites a biomarker that suggested irregular heart rhythms were a key predictor of fatal heart attacks. Using the assumption, doctors prescribed heart-regulating drugs to millions of patients in the 1980s but abruptly halted the practice in 1989 when a long-term study revealed patients were actually more than twice as likely to die of sudden heart failure."
Note to Perrone and Ross: The reason people died was because the drug was prescribed to patients outside of the clinical trial guideline. Ross is using the "generic" definition of a biomarker, meaning biological measure that is linked to a disease state. A biomarker that captured genetic variations explaining why people more likely to die from the drug is now possible to develop using a blood test. I guess we shouldn't use that. Ditto, all those tests that can now screen to see which people respond to certain cancer drugs and avoid needless chemotherapy or which HIV drugs will work for them.
It should also be noted that Ross was one of the biggest loudmouths about the dangers of SSRIs which have been overhyped to the point that prescriptions are down and suicides are up.
This effort to eliminate measures like cholesterol, glycemic index, bone density, blood pressure as conditions of approval is just an effort to slow down drug approval and move it into the dark ages. It is being engineered by those who believe that the current approach to clinical evaluation is corrupt and corporatized. Supporters offer this more rigid and unreachable methods not because they are based on better science but because they reduce the number of new medicines that companies develop. The attack is political, pure and simple.
The battle lines are already being defined: The opponents of the Foundation and Critical Path oppose both because it might advance industry and industry is evil. (Even though most of the research will be done in collaboration with academia and NIH). Because corporations are involved it is inherently evil and corrupt. WHich allow the other side to distort the mission and the science all they want.
The headline in the WP "New FDA Research Center Rife WIth Risks" tells you that Reagan Udall has already been spun. How sick and sad is that?
http://www.washingtonpost.com/wp-dyn/content/article/2007/10/14/AR2007101400722.html
I appreciate Jonathan Cohn's thoughtful response to my post on SCHIP and the Frost family being the poster for SCHIP expansion/renewal. It is obvious we have two different views of how to make health care convenient, predictive and prospective. Indeed, the fight over the bona fides of the Frost family have less to to do with their income or wealth or mine for that matter but really about whether entitlements should be expanded to cover and crowd out private insurance and whether government should be the payor and provider of health care or not.
I supported Part D -- the largest expansion of Medicare in a lifetime -- while most Democrats who supported the same approach in 1999 did not. I did because I thought that adding drug benefits would reduce health care spending overall and that giving people choice would create competition and lower costs. I have always opposed SCHIP because it addressed a problem that did not exist with a solution that made matters worse. We have 4 -5 million kids eligible for Medicaid in 2006 and that was about the same number in 1997. Meanwhile the single payer approach if you will has made it hard for people to enroll in SCHIP. All the while, we have ignored the issue of coverage for illegal workers who make up a huge chunk of the uninsured and the fact that lots of people are just to cheap and irresponsible to buy their own insurance.
But that's the heart of the debate. I think everyone should have access to health care coverage and decent care. I don't think we can guarantee results or equal outcomes and I don't think government does a great job delivering health care coverage. Cohn does. This debate is not over. SCHIP will get refunded but not expanded. And then we can have a debate about whether we want Hillary to run health care (setting up a false set of choices that lead to a single payer system) or let people decide for themselves through insurance deregulation, HSAs, tax credits and retail clinics.
I think conservative ideas on health care will win the day. Why? Because we value freedom as an essential ingredient for excellence in medical science and sustaining dignity in the doctor patient relationship. Without freedom, the freedom to innovate, to prescribe, to choose, to err, medicine suffers.
My thanks again to Mr. Cohn for reshaping the debate around what matters. Here's a link to his post and to his book about the health care system.
http://www.tnr.com/
blog/the_plank?pid=151407
http://www.sickthebook.com
I supported Part D -- the largest expansion of Medicare in a lifetime -- while most Democrats who supported the same approach in 1999 did not. I did because I thought that adding drug benefits would reduce health care spending overall and that giving people choice would create competition and lower costs. I have always opposed SCHIP because it addressed a problem that did not exist with a solution that made matters worse. We have 4 -5 million kids eligible for Medicaid in 2006 and that was about the same number in 1997. Meanwhile the single payer approach if you will has made it hard for people to enroll in SCHIP. All the while, we have ignored the issue of coverage for illegal workers who make up a huge chunk of the uninsured and the fact that lots of people are just to cheap and irresponsible to buy their own insurance.
But that's the heart of the debate. I think everyone should have access to health care coverage and decent care. I don't think we can guarantee results or equal outcomes and I don't think government does a great job delivering health care coverage. Cohn does. This debate is not over. SCHIP will get refunded but not expanded. And then we can have a debate about whether we want Hillary to run health care (setting up a false set of choices that lead to a single payer system) or let people decide for themselves through insurance deregulation, HSAs, tax credits and retail clinics.
I think conservative ideas on health care will win the day. Why? Because we value freedom as an essential ingredient for excellence in medical science and sustaining dignity in the doctor patient relationship. Without freedom, the freedom to innovate, to prescribe, to choose, to err, medicine suffers.
My thanks again to Mr. Cohn for reshaping the debate around what matters. Here's a link to his post and to his book about the health care system.
http://www.tnr.com/
blog/the_plank?pid=151407
http://www.sickthebook.com
Why is the Union of Concerned Scientists putting politics in front of the public health?
http://www.washingtonpost.com/wp-dyn/content/article/2007/10/14/AR2007101400722.html
Consider the statement of Francesca Grifo, a director at the UCS, “Given FDA's track record in the past, I'm not confident in their ability to create something that is free of influence from industry."
Believe it or not, this statement was aimed at, of all things, the bi-partisan crown jewel of current FDA reform legislation – the Reagan/Udall Foundation (aka “the Crtitical Path Foundationâ€), approved by Congress and signed into law late last month, allowing the FDA to work with both industry and academe to accelerate the nascent sciences of genomics and proteomics to help realize the very real potential of a new kind of medicine – personalized medicine -- capable of tailoring highly effective treatments against the underlying causes of specific diseases in individual patients – and perhaps even preventing those diseases from occurring or progressing in the first place
According to Senator Ted Kennedy, the Reagan-Udall Foundation "will make new research tools and techniques available to the entire research community, shortening the time it takes to develop new drugs and reducing costs for patients."
Just what track record is Ms. Gifo referring to anyway?
The hard truth is that many of the most dramatic scientific advances in basic research are difficult to translate into safe and effective medical treatments for patients. Isn’t this something that “concerned†scientists should be concerned about?
Despite the increase in R&D spending, the number of new innovative products being submitted to the FDA for approval is decreasing and the rate of failure is increasing. Almost 50% of applications are failing in late-stage Phase 3 trials. This costs companies millions of extra dollars and is driving up the cost of successfully bringing a new drug to market. In 2003, researchers at Tufts Center for the Study of Drug Development estimated these costs to be $802 million, and some sources suggest that the total cost is closer to $1.7 billion.
As the late Senator Everitt Dirksen said, “A billion here and a billion there, and pretty soon you’re talking about real money.â€
Think about the millions of dollars, pounds and Euros that would be saved by all types and sizes of companies and governments if publicly discussed and vetted biomarkers could be used and used predictably in the drug approval process.
IP questions? You bet – it’s the 800 pound gorilla sitting in the corner. But we must acknowledge, address, and overcome this and other obstacles. Bumps along the road of all sizes must not allow the Critical Path to be the path less traveled.
FDA must assume the lead organizational role, because the agency is at the crossroads of the translational process. FDA is uniquely suited to take a major role in this effort because of their unique cross-industry and cross-cutting knowledge of the hurdles companies and products encounter that are causing them to fail in late stage clinical trials.
The Critical Path must be blazed in partnership. Regulators and industry, patient groups and legislators, FDA and EMEA must work together to help bridge the widening canyon between bench and bedside.
The Union of Concerned Scientists thinks the FDA has “an agenda†– and they’re right – it’s to protect and advance the public health.
http://www.washingtonpost.com/wp-dyn/content/article/2007/10/14/AR2007101400722.html
Consider the statement of Francesca Grifo, a director at the UCS, “Given FDA's track record in the past, I'm not confident in their ability to create something that is free of influence from industry."
Believe it or not, this statement was aimed at, of all things, the bi-partisan crown jewel of current FDA reform legislation – the Reagan/Udall Foundation (aka “the Crtitical Path Foundationâ€), approved by Congress and signed into law late last month, allowing the FDA to work with both industry and academe to accelerate the nascent sciences of genomics and proteomics to help realize the very real potential of a new kind of medicine – personalized medicine -- capable of tailoring highly effective treatments against the underlying causes of specific diseases in individual patients – and perhaps even preventing those diseases from occurring or progressing in the first place
According to Senator Ted Kennedy, the Reagan-Udall Foundation "will make new research tools and techniques available to the entire research community, shortening the time it takes to develop new drugs and reducing costs for patients."
Just what track record is Ms. Gifo referring to anyway?
The hard truth is that many of the most dramatic scientific advances in basic research are difficult to translate into safe and effective medical treatments for patients. Isn’t this something that “concerned†scientists should be concerned about?
Despite the increase in R&D spending, the number of new innovative products being submitted to the FDA for approval is decreasing and the rate of failure is increasing. Almost 50% of applications are failing in late-stage Phase 3 trials. This costs companies millions of extra dollars and is driving up the cost of successfully bringing a new drug to market. In 2003, researchers at Tufts Center for the Study of Drug Development estimated these costs to be $802 million, and some sources suggest that the total cost is closer to $1.7 billion.
As the late Senator Everitt Dirksen said, “A billion here and a billion there, and pretty soon you’re talking about real money.â€
Think about the millions of dollars, pounds and Euros that would be saved by all types and sizes of companies and governments if publicly discussed and vetted biomarkers could be used and used predictably in the drug approval process.
IP questions? You bet – it’s the 800 pound gorilla sitting in the corner. But we must acknowledge, address, and overcome this and other obstacles. Bumps along the road of all sizes must not allow the Critical Path to be the path less traveled.
FDA must assume the lead organizational role, because the agency is at the crossroads of the translational process. FDA is uniquely suited to take a major role in this effort because of their unique cross-industry and cross-cutting knowledge of the hurdles companies and products encounter that are causing them to fail in late stage clinical trials.
The Critical Path must be blazed in partnership. Regulators and industry, patient groups and legislators, FDA and EMEA must work together to help bridge the widening canyon between bench and bedside.
The Union of Concerned Scientists thinks the FDA has “an agenda†– and they’re right – it’s to protect and advance the public health.
You would think Henry Waxman would have learned from the Part D debacle but here he goes again claiming that Medicare "would have saved almost $15 billion this year if the drug plans had administrative costs similar to traditional Medicare's hospital and physician coverage, and discounts on drugs similar to those obtained by the government in Medicaid, the state-federal program for the poor."
This from a "draft" obtained by Sarah Lueck of the WSJ.
http://online.wsj.com/article/SB119222916919857858.html
We all know how reliable Waxman's savings estimates are. Remember the $200 billion in savings from using the VA restrictive formulary approach and the $70 billion in savings from follow-on biologics. So here comes Waxman raking in $150 over ten years through price controls and restrictive formularies ala Medicaid.
I hope the Democrats go down the "Destroy Part D" path again. It was fun last time.
This from a "draft" obtained by Sarah Lueck of the WSJ.
http://online.wsj.com/article/SB119222916919857858.html
We all know how reliable Waxman's savings estimates are. Remember the $200 billion in savings from using the VA restrictive formulary approach and the $70 billion in savings from follow-on biologics. So here comes Waxman raking in $150 over ten years through price controls and restrictive formularies ala Medicaid.
I hope the Democrats go down the "Destroy Part D" path again. It was fun last time.
John McCain demonstrates his ignorance of health care in Iowa -- or maybe it's just political pandering -- you be the judge:
“Pharmaceutical companies must worry less about squeezing additional profits from old medicines by copying the last successful drug and insisting on additional patent protections and focus more on new and innovative medicine.â€
Attention Senator McCain:
America’s pharmaceutical and biotechnology research companies set a new record for biopharmaceutical research spending last year with an investment of $55.2 billion to develop new medicines and vaccines. That's $3.4 billion higher than the previous record of $51.8 billion spent by U.S. companies in 2005.
The research spending of all of America’s biopharmaceutical companies is much higher than the amount spent on biomedical research by the National Institutes of Health and pharmaceutical research companies in other countries.
It may not be popular or politically expedient to admit the truth. But we expect better from Senator McCain.
“Pharmaceutical companies must worry less about squeezing additional profits from old medicines by copying the last successful drug and insisting on additional patent protections and focus more on new and innovative medicine.â€
Attention Senator McCain:
America’s pharmaceutical and biotechnology research companies set a new record for biopharmaceutical research spending last year with an investment of $55.2 billion to develop new medicines and vaccines. That's $3.4 billion higher than the previous record of $51.8 billion spent by U.S. companies in 2005.
The research spending of all of America’s biopharmaceutical companies is much higher than the amount spent on biomedical research by the National Institutes of Health and pharmaceutical research companies in other countries.
It may not be popular or politically expedient to admit the truth. But we expect better from Senator McCain.
Speaking of nightime cold remedies being taken off the market....
Dutch ban famed hallucinatory mushrooms
By TOBY STERLING, Associated Press Writer
AMSTERDAM, Netherlands - The Dutch government said Friday that it will ban the sale of hallucinatory mushrooms, rolling back one element of the country's permissive drug policy after a series of high-profile negative incidents.
http://news.yahoo.com/s/ap/20071012/ap_on_re_eu/netherlands_magic_mushrooms
Dutch ban famed hallucinatory mushrooms
By TOBY STERLING, Associated Press Writer
AMSTERDAM, Netherlands - The Dutch government said Friday that it will ban the sale of hallucinatory mushrooms, rolling back one element of the country's permissive drug policy after a series of high-profile negative incidents.
http://news.yahoo.com/s/ap/20071012/ap_on_re_eu/netherlands_magic_mushrooms
This recent Vioxx liability driven drive to yank infant cough formulas from the shelves is the latest in a series of meaningless gestures that will do nothing to make kids safer or save lives. The leading cause of death and injury among kids are car accidents. I don't see trial lawyers and their allies threatening to sue the auto companies for vehicular manslaughter. But when stupid parents OD their kids on Triaminic or Children's Tylenol for Cough and Cold somehow that's the drug company's fault. As in this case report: "n the third case report, the child tragically died from an overdose of cough and cold medications that likely had been persistently administered because of continued symptoms in the child." I know, I know, the marketing made them do it. People are brain dead until some TV ad programs them to do something lethal. Nothing before or after matters.
I predict there will be a jihad against all pediatric cough formulations soon. The "safety uber alles" crowd smells blood after this victory and won't stop. They see danger lurking everywhere because they believe drug companies have to poison people to make profits.
Risk in life is not an all or nothing proposition. Life is a series of trade-offs, balancing the bad with the good, the bitter with the sweet, etc. Learning how to handle risky situations big and small is part of growing up, becoming an adult. We are infantilizing our culture further with this sort of overreach. You can't buy Claritin-D without a driver's license (but I can buy Viagra over the internet) build treehouses anymore, can't ride a bike without a helmet, can't play soldier, can't even sell cupcakes in school anymore without have some safety nanny get between you and a good time or you and a personal decision.
I predict there will be a jihad against all pediatric cough formulations soon. The "safety uber alles" crowd smells blood after this victory and won't stop. They see danger lurking everywhere because they believe drug companies have to poison people to make profits.
Risk in life is not an all or nothing proposition. Life is a series of trade-offs, balancing the bad with the good, the bitter with the sweet, etc. Learning how to handle risky situations big and small is part of growing up, becoming an adult. We are infantilizing our culture further with this sort of overreach. You can't buy Claritin-D without a driver's license (but I can buy Viagra over the internet) build treehouses anymore, can't ride a bike without a helmet, can't play soldier, can't even sell cupcakes in school anymore without have some safety nanny get between you and a good time or you and a personal decision.
Why are our teeth rotting? Because dentists are making more money then ever, making teeth cleanings and cavity filling more unaffordable than ever before. That's according to Alex Berenson who wrote another article without stealing documents.
In fact Berenson buries the reason dentist salaries are going up: there is a shortage of dentists and the falling number of schools to replace the one's who will be retiring. Meanwhile the disparity in care between rich and poor is the same old story....Medicaid rates are too low and when dentists do provide care, patients rarely show up. So even if reimbursement rates are bumped up patients don't show and doctors don't get paid. That's something Berenson ignores in his attack on the profession even though the federal government sees it as of tactical importance. Here's a glimpse from a government study about the dental divide...
"A common complaint among dentists concerns patients who do not keep their appointments. Missed appointments cause resentment among dentists because of the office management and financial problems they create. More importantly, the patient does not receive a needed service. The likelihood of a patient keeping a dental appointment is improved with a system of case management that addresses the logistical, cultural and behavioral barriers to dental care. Medicaid can pay for case management as a medical service or as an administrative activity."
http://www.hrsa.gov/medicaidprimer/oral_part3only.htm
I think part of the problem is that people have gotten used to only getting care when it's paid for, not when it is necessary so they shrug off going to the dentist twice a year. Then there is the failure to brush, floss, rinse, etc.
Still Berenson's article does pick up on themes and concerns articulated in the Surgeon General's report on Oral Health in 2000. A public health solution will not work, but a retail or market driven one might. Of course the dental profession is digging it's heels in on not letting hygenists do cleanings and exams on their own. But that won't last long. My prediction: Dentistry will go the way of the retail health clinics. Cleaning, xrays and exams for $60 with evening hours.
http://www.nytimes.com/2007/10/11/business/11decay.html?_r=2&pagewanted=2&ref=health&oref=slogin
In fact Berenson buries the reason dentist salaries are going up: there is a shortage of dentists and the falling number of schools to replace the one's who will be retiring. Meanwhile the disparity in care between rich and poor is the same old story....Medicaid rates are too low and when dentists do provide care, patients rarely show up. So even if reimbursement rates are bumped up patients don't show and doctors don't get paid. That's something Berenson ignores in his attack on the profession even though the federal government sees it as of tactical importance. Here's a glimpse from a government study about the dental divide...
"A common complaint among dentists concerns patients who do not keep their appointments. Missed appointments cause resentment among dentists because of the office management and financial problems they create. More importantly, the patient does not receive a needed service. The likelihood of a patient keeping a dental appointment is improved with a system of case management that addresses the logistical, cultural and behavioral barriers to dental care. Medicaid can pay for case management as a medical service or as an administrative activity."
http://www.hrsa.gov/medicaidprimer/oral_part3only.htm
I think part of the problem is that people have gotten used to only getting care when it's paid for, not when it is necessary so they shrug off going to the dentist twice a year. Then there is the failure to brush, floss, rinse, etc.
Still Berenson's article does pick up on themes and concerns articulated in the Surgeon General's report on Oral Health in 2000. A public health solution will not work, but a retail or market driven one might. Of course the dental profession is digging it's heels in on not letting hygenists do cleanings and exams on their own. But that won't last long. My prediction: Dentistry will go the way of the retail health clinics. Cleaning, xrays and exams for $60 with evening hours.
http://www.nytimes.com/2007/10/11/business/11decay.html?_r=2&pagewanted=2&ref=health&oref=slogin
Jonathan Cohn is The New Republic's leading voice in support of universal health care. He has taken issue with conservative who have criticized Democrats for using middle and upper class individuals as walking and talking posters for their efforts to increase the welfare state. Most recently conservative bloggers, including me, have taken issue with Democrats deciding to have a 12 year boy give a response to President Bush's veto of SCHIP. It seemed tacky at the time, sort of a cheap shot considering the bill Bush nixed extends government insurance to folks making $83K a year (no asset test folks!) at a time when Medicaid rolls are declining. But then I learned that picking the kid was Families USA's idea and well, the fact they have moved from lying about drug prices to dragging a family into the middle of a political fight does not surprise me at all.
So of course Cohn tries to blame "right wingers" for picking on a kid. Let's be clear. The issue is whether SCHIP should be expanded to middle income families. At least that's what Cohn is saying:
"We know that people with modest incomes are having a harder time paying their medical bills, because insurance is getting so pricey and--increasingly--the benefits available leave them exposed to high out-of-pocket expenses. We also know this is particularly true of people who can't get coverage through large employers--a class of people that is expanding as the business community slowly extricates itself from the mess of providing workers with insurance.
In other words, it's not just the most destitute Americans who need assistance getting health insurance. It's people who have jobs, make a decent living, and own their homes. And when medical crisis hits, they're forced to take drastic steps--like selling their homes, depleting life savings, declaring bankruptcy, or simply going without the care they and their loved ones need. Unless, of course, the government provides them with insurance at affordable rates. "
First of all, Cohn is immune to the facts: many people simply don't buy insurance that is affordable (and it is affordable) in many cases so they create a medical crisis in many cases.... The fastest growing segment of the uninsured are people making $70k or more and whose incomes are growing. Explain that. Meanwhile Medicaid roles are declining.
Cohn also sees health insurance as a big pre-paid security blanket. Zero deductibles. No copays. Coverage for everything. Dream on boychick. That does not even exist in France, your health care wet dream. That system is broke so Sarkozy is installing gatekeepers, co-pays, the works. Soon France will be one big HMO. Even GM's employees are cutting back. You see health care as an all you can eat buffet, not as personal responsbility.
Ultimately, Cohn misrepresents the conservative position on health care. It is not opposition to making coverage affordable. Rather, the conservative position is to take the favorable tax breaks and purchasing power corporations have and give it to individuals. So instead of SCHIP why not advanceable tax credits and purchasing pools, prefunded HSAs? Why is Cohn so opposed to that? For the same reason liberals are hysterical about declining Medicaid enrollment and opposed Part D. They want people dependent.
The fight is not about a family and whether they should have access to affordable and convenient care. That's a given. The fight is about whether Americans should be herded into a single payer system supported by Hillary, Cohn and others where the sort of high tech care Graeme Frost needs and deserves will be denied him regularly. With HSAs, tax credits and consumer choice he and his family will have control over the medical decisions that shape his life, not a bureaucrat or some comparative effectiveness institute. In Britain, Germany, Canada or even France where the doctors strike more than they see patients, Graeme would get inferior care. He would be less cared for and less valued.
In the final analysis, conservative care more about his future than Cohn, Ezra Klein and his kind ever will. Klein, Cohn and Families USA just want to expand the welfare state. I dare say my conservative colleagues want to preserve the possibilities that medical progress offer to extend life and enhance the human condition.
http://www.tnr.com/blog/the_plank?pid=150639
So of course Cohn tries to blame "right wingers" for picking on a kid. Let's be clear. The issue is whether SCHIP should be expanded to middle income families. At least that's what Cohn is saying:
"We know that people with modest incomes are having a harder time paying their medical bills, because insurance is getting so pricey and--increasingly--the benefits available leave them exposed to high out-of-pocket expenses. We also know this is particularly true of people who can't get coverage through large employers--a class of people that is expanding as the business community slowly extricates itself from the mess of providing workers with insurance.
In other words, it's not just the most destitute Americans who need assistance getting health insurance. It's people who have jobs, make a decent living, and own their homes. And when medical crisis hits, they're forced to take drastic steps--like selling their homes, depleting life savings, declaring bankruptcy, or simply going without the care they and their loved ones need. Unless, of course, the government provides them with insurance at affordable rates. "
First of all, Cohn is immune to the facts: many people simply don't buy insurance that is affordable (and it is affordable) in many cases so they create a medical crisis in many cases.... The fastest growing segment of the uninsured are people making $70k or more and whose incomes are growing. Explain that. Meanwhile Medicaid roles are declining.
Cohn also sees health insurance as a big pre-paid security blanket. Zero deductibles. No copays. Coverage for everything. Dream on boychick. That does not even exist in France, your health care wet dream. That system is broke so Sarkozy is installing gatekeepers, co-pays, the works. Soon France will be one big HMO. Even GM's employees are cutting back. You see health care as an all you can eat buffet, not as personal responsbility.
Ultimately, Cohn misrepresents the conservative position on health care. It is not opposition to making coverage affordable. Rather, the conservative position is to take the favorable tax breaks and purchasing power corporations have and give it to individuals. So instead of SCHIP why not advanceable tax credits and purchasing pools, prefunded HSAs? Why is Cohn so opposed to that? For the same reason liberals are hysterical about declining Medicaid enrollment and opposed Part D. They want people dependent.
The fight is not about a family and whether they should have access to affordable and convenient care. That's a given. The fight is about whether Americans should be herded into a single payer system supported by Hillary, Cohn and others where the sort of high tech care Graeme Frost needs and deserves will be denied him regularly. With HSAs, tax credits and consumer choice he and his family will have control over the medical decisions that shape his life, not a bureaucrat or some comparative effectiveness institute. In Britain, Germany, Canada or even France where the doctors strike more than they see patients, Graeme would get inferior care. He would be less cared for and less valued.
In the final analysis, conservative care more about his future than Cohn, Ezra Klein and his kind ever will. Klein, Cohn and Families USA just want to expand the welfare state. I dare say my conservative colleagues want to preserve the possibilities that medical progress offer to extend life and enhance the human condition.
http://www.tnr.com/blog/the_plank?pid=150639
WSJ blogger Peter Loftus writes, “Meter Set to Run on J&J’s Cash-Back Deal†– but it’s the meter on physician empowerment and patient choice that is already ticking.
In an attempt to get NICE to reimburse Velcade, Johnson & Johnson made the UK regulatory body an offer they couldn’t refuse – the “Velcade Response Scheme†-- a money-back guarantee for the cancer drug.
The scheme changed the equation. “For those who may get a full response or a partial response … it’s a cost-effective intervention for the National Health Service,†Andrew Dillon, chief executive of NICE, told Dow Jones Newswires. “Narrowing down to patients getting the best response makes it worth it.†A government proposal formalizing the deal is expected to become final on Oct. 24.
But the measures of “success,†are debatable. A “response†would be considered to be when a patient achieves a 50% or more overall reduction in their paraprotein after four cycles of Velcade. Only patients who achieve this 50% plus reduction in their paraprotein will continue on Velcade. No rebates will be issued for patients who achieve a full or partial response. Also, the drug is recommended only for people who are having their first relapse, who have received one prior therapy and who have undergone a bone marrow transplant or have been deemed unsuitable for a transplant.
Non-responders at 4 cycles will not have the option of continuing therapy because NICE does not consider that there is sufficient clinical evidence to show that those patients who have not responded well after four cycles, would gain any benefit by having four further cycles. Hmm.
Loftus write that, “The Velcade rebate program is the first of its kind in the U.K. and may be a harbinger of things to come there and elsewhere.â€
Translation – “in the United States.â€
In a matter of weeks, J&J is expected to be on the hook for the full cost of Velcade treatment for multiple myeloma patients who don’t improve "sufficiently" after four cycles of treatment with medicine.
But just what does “sufficiently mean? What type of "evidence" should be used? And who defines it, physicians or the government? That question has been asked and answered in Great Britain.
There may very well "always be an England," but there won't always be the drugs you need to survive if you live there. Welcome to the world of heathcare technology assessment aka comparative effectiveness aka evidence-based medicine.
When it comes down to brass tacks, what all these fancy phrases means for patients is "sorry -- no medicines for you." So much for "universal" health care. "Government" health care is more like it
In an attempt to get NICE to reimburse Velcade, Johnson & Johnson made the UK regulatory body an offer they couldn’t refuse – the “Velcade Response Scheme†-- a money-back guarantee for the cancer drug.
The scheme changed the equation. “For those who may get a full response or a partial response … it’s a cost-effective intervention for the National Health Service,†Andrew Dillon, chief executive of NICE, told Dow Jones Newswires. “Narrowing down to patients getting the best response makes it worth it.†A government proposal formalizing the deal is expected to become final on Oct. 24.
But the measures of “success,†are debatable. A “response†would be considered to be when a patient achieves a 50% or more overall reduction in their paraprotein after four cycles of Velcade. Only patients who achieve this 50% plus reduction in their paraprotein will continue on Velcade. No rebates will be issued for patients who achieve a full or partial response. Also, the drug is recommended only for people who are having their first relapse, who have received one prior therapy and who have undergone a bone marrow transplant or have been deemed unsuitable for a transplant.
Non-responders at 4 cycles will not have the option of continuing therapy because NICE does not consider that there is sufficient clinical evidence to show that those patients who have not responded well after four cycles, would gain any benefit by having four further cycles. Hmm.
Loftus write that, “The Velcade rebate program is the first of its kind in the U.K. and may be a harbinger of things to come there and elsewhere.â€
Translation – “in the United States.â€
In a matter of weeks, J&J is expected to be on the hook for the full cost of Velcade treatment for multiple myeloma patients who don’t improve "sufficiently" after four cycles of treatment with medicine.
But just what does “sufficiently mean? What type of "evidence" should be used? And who defines it, physicians or the government? That question has been asked and answered in Great Britain.
There may very well "always be an England," but there won't always be the drugs you need to survive if you live there. Welcome to the world of heathcare technology assessment aka comparative effectiveness aka evidence-based medicine.
When it comes down to brass tacks, what all these fancy phrases means for patients is "sorry -- no medicines for you." So much for "universal" health care. "Government" health care is more like it
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
