Latest Drugwonks' Blog
I was in the middle of asking a panel of Euro reimbursement experts including Sir Michael Rawlins who helped create NICE about whether the $50K per QALY was too low and even authoritative (since Sir Michael noted that the $50K per QALY had no empirical basis) when he announced he could not stay to listen to speech and walked out...
I guess what I had to say was not worth $50K per QALY
I guess what I had to say was not worth $50K per QALY
The comparative effectiveness hurdle is firmly in place throughout Europe and it is all focusing on new drugs. And it is all one size fits all evaluations of whether or not there is improvement in actual benefit for drugs and benefit can be a matter of debate and deviation...and that is only the first part of the CE analysis. Then you have to demonstrate whether or not it is cost-effective
I find it interesting that health plans here that fought national health care have no problem importing the operating system of government medicine. The average time for a coverage decision is a year. Would health plans wait a year to get their premiums?
I find it interesting that health plans here that fought national health care have no problem importing the operating system of government medicine. The average time for a coverage decision is a year. Would health plans wait a year to get their premiums?
The quote is John Milton, but the practice is pure government health care.
Is this any way to treat a veteran... or anyone else for that matter ... like seniors on Part D?
Veterans filing disability claims with the Veterans Affairs Department wait for an average of almost six months for a response -- about six times longer than is typical in the private sector.
Pending disability claims with the VA take an average of 177 days to process, according to VA records. For some, the wait time is almost a year.
And for veterans appealing a decision on a claim, the average wait time is 657 days.
According to America's Health Insurance Plans (AHIP), for people filing disability claims with insurance companies, about 75 percent to 80 percent of claims are handled within 30 days. Federal law requires disability claims with private insurers to be settled within 45 days (although extensions of 30 days or longer are possible).
Here's the full story:
http://www.washingtontimes.com/national/20070508-122145-5910r.htm
Only in America does VA mean "stop."
Is this any way to treat a veteran... or anyone else for that matter ... like seniors on Part D?
Veterans filing disability claims with the Veterans Affairs Department wait for an average of almost six months for a response -- about six times longer than is typical in the private sector.
Pending disability claims with the VA take an average of 177 days to process, according to VA records. For some, the wait time is almost a year.
And for veterans appealing a decision on a claim, the average wait time is 657 days.
According to America's Health Insurance Plans (AHIP), for people filing disability claims with insurance companies, about 75 percent to 80 percent of claims are handled within 30 days. Federal law requires disability claims with private insurers to be settled within 45 days (although extensions of 30 days or longer are possible).
Here's the full story:
http://www.washingtontimes.com/national/20070508-122145-5910r.htm
Only in America does VA mean "stop."
Bad news: Senator Byron Flickertail's ill-considered drug importation amendment was approved in a voice vote.
Good news: The Senate voted 49-40 in favor of an amendment from Senator Thad Cochran requiring certification from the Secretary of Health and Human Services that importation can be done safely.
That's something that Secretaries of HHS from both parties have never been able to do. Not Secretary Shalala. Not Secretary Thompson. Why? Because allowing medicines from outside our closed regulatory system into the legitimate American supply chain would lead to a safety nightmare. Also, according to multiple sources including the CBO, it would lead to insignificant savings.
Propaganda is one thing. Public health is another.
Talk about a no-brainer risk/benefit equation.
Good news: The Senate voted 49-40 in favor of an amendment from Senator Thad Cochran requiring certification from the Secretary of Health and Human Services that importation can be done safely.
That's something that Secretaries of HHS from both parties have never been able to do. Not Secretary Shalala. Not Secretary Thompson. Why? Because allowing medicines from outside our closed regulatory system into the legitimate American supply chain would lead to a safety nightmare. Also, according to multiple sources including the CBO, it would lead to insignificant savings.
Propaganda is one thing. Public health is another.
Talk about a no-brainer risk/benefit equation.
Roger Pilon's Cato Institute still believes that using protectionist policies from other nation's is perfectly consistent with free market libertarian principles...maybe he can make the case for reinporting gasoline from the Saudis at highly subsidized prices to lower gas prices here.
http://biz.yahoo.com/cnnm/070504/050407_gas_demand.html?.v=1&.pf=family-home
http://biz.yahoo.com/cnnm/070504/050407_gas_demand.html?.v=1&.pf=family-home
For those pols and pundits who think that we need a health care system "just like Europe," some harsh reality from the other side of the Pond.
The Observer (one of the leading liberal-left newspapers in Europe) reports that British doctors will take the historic step of admitting for the first time that many health treatments will be rationed in the future because the NHS cannot cope with spiraling demand from patients.
In a major report, the British Medical Association will warn that patients face a bleak future because they will increasingly be denied treatments. The BMA will urge the NHS to be much more explicit about what it can realistically afford to do and ask political leaders to engage in an open, honest debate about rationing.
Dr Michael Wilks, one of the BMA's senior office holders, revealed the organization’s radical thinking in a recent letter to its 139,000 members updating them on the progress of the BMA working group. He told them the group had concluded that '"while the service should remain universal, the challenges raise questions about how comprehensive the service can continue to be. This will depend on whether politicians and the taxpayer are prepared to contemplate either increasing expenditure or explicit rationing."
Here's a link to the Observer article:
http://observer.guardian.co.uk/uk_news/story/0,,2073633,00.html
Additional recommended reading includes Stephen Pollard's comments which can be found at http://cnehealth.org/
The Observer (one of the leading liberal-left newspapers in Europe) reports that British doctors will take the historic step of admitting for the first time that many health treatments will be rationed in the future because the NHS cannot cope with spiraling demand from patients.
In a major report, the British Medical Association will warn that patients face a bleak future because they will increasingly be denied treatments. The BMA will urge the NHS to be much more explicit about what it can realistically afford to do and ask political leaders to engage in an open, honest debate about rationing.
Dr Michael Wilks, one of the BMA's senior office holders, revealed the organization’s radical thinking in a recent letter to its 139,000 members updating them on the progress of the BMA working group. He told them the group had concluded that '"while the service should remain universal, the challenges raise questions about how comprehensive the service can continue to be. This will depend on whether politicians and the taxpayer are prepared to contemplate either increasing expenditure or explicit rationing."
Here's a link to the Observer article:
http://observer.guardian.co.uk/uk_news/story/0,,2073633,00.html
Additional recommended reading includes Stephen Pollard's comments which can be found at http://cnehealth.org/
As BIO kicks off in Boston, so too does a new magazine, The Journal of Life Sciences. Check out the website at http://www.tjols.com.
Today the site features a commentary by Barack Obama. Here are a few select paragraphs ...
"We know that all human beings are 99.9 percent identical in genetic makeup, but differences in the remaining 0.1 percent hold important clues about the causes of disease and response to drugs. Simply put, the study of genomics will help us learn why some people get sick and others do not, and use this information to better prevent and treat disease."
"The relatively new field of genomics is key to the practice of personalized medicine. Personalized medicine is the use of genomic and molecular data to better target the delivery of health care, facilitate the discovery and clinical testing of new products, and help determine a patient’s predisposition to a particular disease or condition."
"Personalized medicine represents a revolutionary and exciting change in the fundamental approach and practice of medicine."
"Realizing the promise of personalized medicine will require continued federal leadership and agency collaboration; expansion and acceleration of genomics research; a capable genomics workforce; incentives to encourage development of genomic tests and therapies; and greater attention to the quality of genetic tests, direct-to-consumer advertising and use of personal genomic information."
Here's a link to the entire piece:
http://www.tjols.com/web_new_frontier.jsp
If the Senator keeps this up, we may have to invite him to join our organization.
Today the site features a commentary by Barack Obama. Here are a few select paragraphs ...
"We know that all human beings are 99.9 percent identical in genetic makeup, but differences in the remaining 0.1 percent hold important clues about the causes of disease and response to drugs. Simply put, the study of genomics will help us learn why some people get sick and others do not, and use this information to better prevent and treat disease."
"The relatively new field of genomics is key to the practice of personalized medicine. Personalized medicine is the use of genomic and molecular data to better target the delivery of health care, facilitate the discovery and clinical testing of new products, and help determine a patient’s predisposition to a particular disease or condition."
"Personalized medicine represents a revolutionary and exciting change in the fundamental approach and practice of medicine."
"Realizing the promise of personalized medicine will require continued federal leadership and agency collaboration; expansion and acceleration of genomics research; a capable genomics workforce; incentives to encourage development of genomic tests and therapies; and greater attention to the quality of genetic tests, direct-to-consumer advertising and use of personal genomic information."
Here's a link to the entire piece:
http://www.tjols.com/web_new_frontier.jsp
If the Senator keeps this up, we may have to invite him to join our organization.
Recently Congress considered adding cost-effectiveness as a criterion for selecting and paying for medicines under Medicare.
This model (variously called “evidence-based medicine,†“healthcare technology assessment,†or "comparative effectivenessâ€) relies heavily on findings from randomized clinical trials. While these trials are essential to demonstrating the safety and efficacy of new medical products, the results are based on large population averages that rarely if ever will tell us which treatments are “best†for which patients. That is why it is so critically important for the physician to maintain his or her ability to combine study findings with their expertise and knowledge of the individual in order to make the optimal treatment decisions.
Government sponsored studies that conduct head-to-head comparisons of drugs in "real world’"clinical settings are regarded as a valuable source of information for such coverage and reimbursement decisions -- if not for making clinical decisions. Two such studies, the Clinical Antipsychotic Trials in Intervention Effectiveness or CATIE study and the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) were two such “practice based†clinical trials, sponsored in part by the National Institutes of Health, to determine whether older medicines were as effective in achieving certain clinical outcomes as newer ones.
While media reports and the government agencies that sponsored the studies claimed that “older and cheaper†were equally effective, these conclusions were not without critics or controversy.
The Center for Medicine in the Public Interest held a day long conference on Media, Medicine and the Public Interest in Washington DC on January 26, 2007 that included an expert panel on the conduct and implications of CATIE and ALLHAT.
And when we say "expert" we mean "expert." Panelists included Hebert Meltzer, MD who helped to design CATIE, Michael Weber, MD, similarly involved with ALLHAT, Dr. Susan Horn of the Institute for Clinical Outcomes Research, Dr. David Shern, President and CEO of the National Mental Health Association, Ralph Snyderman, MD of Duke University, and Matt Herper of Forbes.
The panel was chaired by Kate Rawson, senior editor of th RPM Report, who also edited the panel transcripts.
Here is a link to the paper, ALLHAT and CATIE Reconsidered: Reflections on Big Studies and Evidence Based Medicine as the Measure of Comparative Effectiveness.
Download file
Thoughts and comments most welcome.
This model (variously called “evidence-based medicine,†“healthcare technology assessment,†or "comparative effectivenessâ€) relies heavily on findings from randomized clinical trials. While these trials are essential to demonstrating the safety and efficacy of new medical products, the results are based on large population averages that rarely if ever will tell us which treatments are “best†for which patients. That is why it is so critically important for the physician to maintain his or her ability to combine study findings with their expertise and knowledge of the individual in order to make the optimal treatment decisions.
Government sponsored studies that conduct head-to-head comparisons of drugs in "real world’"clinical settings are regarded as a valuable source of information for such coverage and reimbursement decisions -- if not for making clinical decisions. Two such studies, the Clinical Antipsychotic Trials in Intervention Effectiveness or CATIE study and the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) were two such “practice based†clinical trials, sponsored in part by the National Institutes of Health, to determine whether older medicines were as effective in achieving certain clinical outcomes as newer ones.
While media reports and the government agencies that sponsored the studies claimed that “older and cheaper†were equally effective, these conclusions were not without critics or controversy.
The Center for Medicine in the Public Interest held a day long conference on Media, Medicine and the Public Interest in Washington DC on January 26, 2007 that included an expert panel on the conduct and implications of CATIE and ALLHAT.
And when we say "expert" we mean "expert." Panelists included Hebert Meltzer, MD who helped to design CATIE, Michael Weber, MD, similarly involved with ALLHAT, Dr. Susan Horn of the Institute for Clinical Outcomes Research, Dr. David Shern, President and CEO of the National Mental Health Association, Ralph Snyderman, MD of Duke University, and Matt Herper of Forbes.
The panel was chaired by Kate Rawson, senior editor of th RPM Report, who also edited the panel transcripts.
Here is a link to the paper, ALLHAT and CATIE Reconsidered: Reflections on Big Studies and Evidence Based Medicine as the Measure of Comparative Effectiveness.
Download file
Thoughts and comments most welcome.
my column in M,M & M just out - with a fresh look at the scalded IBS drug -
For many patients suffering from Irritable Bowel Syndrome (IBS) with severe
constipation, Novartis¹ Zelnorm was a miracle treatment. But the current
focus on negative aspects of the drug has placed an unfortunate cloud over
its use.
What happened? A total of 29 placebo-controlled, 1-3 month trials of more
than 11,600 patients receiving Zelnorm showed a slight increase in the risk
of cardiovascular events‹angina, heart attacks and strokes‹over placebo
(0.1% versus 0.01%).
But these studies‹for the most part‹involved patients in higher risk groups
than those for whom myself and
others would prescribe it, and for some also a longer use
of the drug. Plus, many physicians were already aware of this potential
problem, which was why we gave the drug
mainly to younger people with lower risk for cardiovascular events.
The Food and Drug Administration acted quickly in its public advisory and
Novartis has agreed to stop marketing the drug and selling it in the US.
This is certainly a responsible and cautious reaction. So why aren¹t the FDA
and Novartis being praised for their actions on behalf of drug safety?
The answer is that we currently live in an unhealthy climate of drug company
bashing where every newly demonstrated risk is an opportunity for a new
round of criticism. Those who engage in this habit tend to justify it as a
way to protect society, though there is certainly a tradeoff‹excess caution
and fear of attack is certainly not conducive to research and development,
so don¹t be surprised if drug discoveries continue to decline.
It makes sense to keep Zelnorm in reserve for those in lower risk groups who
really need it. It also makes sense to not inflame the news of its slight
increased risk of heart disease and stroke and use it as a pulpit to start
criticizing everyone in sight.
For many patients suffering from Irritable Bowel Syndrome (IBS) with severe
constipation, Novartis¹ Zelnorm was a miracle treatment. But the current
focus on negative aspects of the drug has placed an unfortunate cloud over
its use.
What happened? A total of 29 placebo-controlled, 1-3 month trials of more
than 11,600 patients receiving Zelnorm showed a slight increase in the risk
of cardiovascular events‹angina, heart attacks and strokes‹over placebo
(0.1% versus 0.01%).
But these studies‹for the most part‹involved patients in higher risk groups
than those for whom myself and
others would prescribe it, and for some also a longer use
of the drug. Plus, many physicians were already aware of this potential
problem, which was why we gave the drug
mainly to younger people with lower risk for cardiovascular events.
The Food and Drug Administration acted quickly in its public advisory and
Novartis has agreed to stop marketing the drug and selling it in the US.
This is certainly a responsible and cautious reaction. So why aren¹t the FDA
and Novartis being praised for their actions on behalf of drug safety?
The answer is that we currently live in an unhealthy climate of drug company
bashing where every newly demonstrated risk is an opportunity for a new
round of criticism. Those who engage in this habit tend to justify it as a
way to protect society, though there is certainly a tradeoff‹excess caution
and fear of attack is certainly not conducive to research and development,
so don¹t be surprised if drug discoveries continue to decline.
It makes sense to keep Zelnorm in reserve for those in lower risk groups who
really need it. It also makes sense to not inflame the news of its slight
increased risk of heart disease and stroke and use it as a pulpit to start
criticizing everyone in sight.
From the Washington Times: "Mr. Dorgan's bill would implement an approval standard for foreign-made drugs in which the manufacturer notifies the FDA of differences between the drug and the corresponding U.S. label. "
Would Mr. Dorgan accept that as an approval standard for imported food as well?
Would Mr. Dorgan accept that as an approval standard for imported food as well?
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.
