Latest Drugwonks' Blog
Health Affairs is late to the party when it comes to personalized medicine. It has a roundtable of oncologists talking about treating cancers and people differently right off the bat like it was something new. Better late than never. But some people still like using blunt instruments. Here is the managed care view of comparative effectiveness courtesy of Lee Newcomer business leader of Oncology Services at UnitedHealthcare in Minneapolis.
"Newcomer also argues that, following the example of the United Kingdom, the U.S. government should establish cost-effectiveness guidelines: “The government could say that anything more than $40,000 per year of life gained is unacceptable.â€
As we all know by now, the UK has the lowest five year survival rates across the board for all cancers and has increasing death rates for many cancers thanks to this approach.
My suggestion to Newcomer: Apply that metric to you and your family. Look them in the face and tell them that their lives are not worth more than a Honda Prius.
http://us.f328.mail.yahoo.com/ym/ShowLetter?MsgId=1664_41790369_156635_1276_12940_0_674597_31516_348646986&Idx=9&YY=53821&y5beta=yes&y5beta=yes&inc=25&order=down&sort=date&pos=0&view=&head=&box=Inbox
"Newcomer also argues that, following the example of the United Kingdom, the U.S. government should establish cost-effectiveness guidelines: “The government could say that anything more than $40,000 per year of life gained is unacceptable.â€
As we all know by now, the UK has the lowest five year survival rates across the board for all cancers and has increasing death rates for many cancers thanks to this approach.
My suggestion to Newcomer: Apply that metric to you and your family. Look them in the face and tell them that their lives are not worth more than a Honda Prius.
http://us.f328.mail.yahoo.com/ym/ShowLetter?MsgId=1664_41790369_156635_1276_12940_0_674597_31516_348646986&Idx=9&YY=53821&y5beta=yes&y5beta=yes&inc=25&order=down&sort=date&pos=0&view=&head=&box=Inbox
Here's the right question to ask: Would Merck and Schering-Plough knowingly try to cover up data about their drugs? The logical answer is no. Are delays common in producing results. Yes. Have some of the people that Matt Herper and Alex Berenson been involved in scrubbing or tossing out or re-analyzing clinical trial data? Yes. Must we remind the MSM about Nissen's role in the Atherogenics trial or Matt's coverage of that story?
Well here goes:
http://www.thestreet.com/pf/comment/adamfeuerstein/10195643.html
But AGI-1067 has been dogged by controversy ever since AtheroGenics released interim results from a phase II study known as CART 2 in late September. While AtheroGenics claimed that the interim analysis was positive, critics charged the company with manipulating results in the drug's favor. It was hoped that final data from the CART 2 study would settle the argument.
Data Are Final, but There's More Debate
Monday, those final CART 2 study results were made public, but it doesn't appear as if the controversy over AGI-1067 will subside any time soon.
AtheroGenics said that AGI-1067 was able to reduce the level of arterial plaque by an average of 2.3% over 12 months, a statistically significant amount when compared with the patients' own baseline measurements. Patients in the placebo arm of the study saw only 0.8% reduction in their plaque levels from baseline.
While patients taking AGI-1067 did better than patients in the placebo arm of the study, the relative benefit between the two groups was not statistically significant, AtheroGenics said.
Furthermore, the data from the final analysis were worse than what was reported previously. In the interim analysis, conducted on fewer patients, AGI-1067 produced a 3.8% reduction in arterial plaque.
AtheroGenics said that treatment with AGI-1067 also produced a statistically significant reduction in levels of myeloperoxidase (MPO), an inflammatory biomarker that correlates with future cardiovascular events. High levels of MPO have been linked to increased risk of heart attack, the company said.
But the company did not present any data linking AGI-1067 to reductions in C-reactive protein, a much more widely recognized clinical biomarker for inflammation and cardiovascular risk.
As with the interim analysis, the final analysis was conducted at two leading hospitals -- Montreal Heart Institute and the Cleveland Clinic. The confirmatory analysis conducted by the Cleveland Clinic, not prespecified in the study's protocol, was one of the reasons some critics felt the AGI-10687 data were misleading, especially because doctors at Cleveland Clinic eliminated some patients from the study because their arterial scans were not readable.
In September, Dr. Steven Nissen of the Cleveland Clinic defended his role in analyzing AGI-1067, calling the drug promising if data could be verified in a late-stage study. But Dr. Eric Topol, another leading cardiologist from the Cleveland Clinic, criticized AtheroGenics and the way CART 2 data were analyzed.
There was no comment Monday from Nissen in AtheroGenics' press release and he was missing from the company's conference call. But Dr. Jean Claude Tardif of Montreal Heart, the lead investigator in the CART 2 study, was supportive.
Here's how Herper handled the Nissen involvement in the Atherogenics trial
AtheroGenics first rose to prominence by touting AGI-1067 as a treatment for inflammation of the arteries. The small biotech rushed into its late-stage study, at a cost of more than $40 million, to try to prove the drug reduced heart attacks, strokes, deaths and surgical procedures.
"But the company badly handled its midstage data, eroding investors' trust. One study, called CART-2, was designed to show that AGI-1067 prevented the buildup of cholesterol plaque in the arteries, as measured by an ultrasound probe. For some reason, Medford and his team were troubled by the results.
AtheroGenics brought in a second scientist, Steven Nissen of the Cleveland Clinic, to do a new analysis of the data. Nissen's analysis seemed to show that the drug worked at clearing out artery plaque, but an analysis by Jean-Claude Tardif of the Montreal Heart Institute, who collected the ultrasound data, was inconclusive."
http://www.forbes.com/sciencesandmedicine/2007/03/19/atherogenics-cardiac-heart-biz-bizhealth-cx_mh_0319cardiac.html
As for Berenson who quoted Nissen and Psaty who was rebuked by NCI for scaring people about the cancer risks of calcium channel blockers, the failure to handle the difficulties about conducting randomized clinical trials with all the scans, blood samples, etc and then adding in a comparative element, well....par for the course. At least this garbage is now in the business section.
But all this speaks to is the pressure to sell papers rather than report on "boring" science.The Atherogenics data could use some re-analysis of subpopulations but when you are trying to be a blockbuster you try to be all things to all people and wind up showing no difference.
So in the end the real story is the limited value of randomized clinical trials in an era of personalized medicine. That's not sexy cause it's science and doesn't have good guys or bad guys or advance Nissen's career. But it's closer to the truth. Which is often boring.
Well here goes:
http://www.thestreet.com/pf/comment/adamfeuerstein/10195643.html
But AGI-1067 has been dogged by controversy ever since AtheroGenics released interim results from a phase II study known as CART 2 in late September. While AtheroGenics claimed that the interim analysis was positive, critics charged the company with manipulating results in the drug's favor. It was hoped that final data from the CART 2 study would settle the argument.
Data Are Final, but There's More Debate
Monday, those final CART 2 study results were made public, but it doesn't appear as if the controversy over AGI-1067 will subside any time soon.
AtheroGenics said that AGI-1067 was able to reduce the level of arterial plaque by an average of 2.3% over 12 months, a statistically significant amount when compared with the patients' own baseline measurements. Patients in the placebo arm of the study saw only 0.8% reduction in their plaque levels from baseline.
While patients taking AGI-1067 did better than patients in the placebo arm of the study, the relative benefit between the two groups was not statistically significant, AtheroGenics said.
Furthermore, the data from the final analysis were worse than what was reported previously. In the interim analysis, conducted on fewer patients, AGI-1067 produced a 3.8% reduction in arterial plaque.
AtheroGenics said that treatment with AGI-1067 also produced a statistically significant reduction in levels of myeloperoxidase (MPO), an inflammatory biomarker that correlates with future cardiovascular events. High levels of MPO have been linked to increased risk of heart attack, the company said.
But the company did not present any data linking AGI-1067 to reductions in C-reactive protein, a much more widely recognized clinical biomarker for inflammation and cardiovascular risk.
As with the interim analysis, the final analysis was conducted at two leading hospitals -- Montreal Heart Institute and the Cleveland Clinic. The confirmatory analysis conducted by the Cleveland Clinic, not prespecified in the study's protocol, was one of the reasons some critics felt the AGI-10687 data were misleading, especially because doctors at Cleveland Clinic eliminated some patients from the study because their arterial scans were not readable.
In September, Dr. Steven Nissen of the Cleveland Clinic defended his role in analyzing AGI-1067, calling the drug promising if data could be verified in a late-stage study. But Dr. Eric Topol, another leading cardiologist from the Cleveland Clinic, criticized AtheroGenics and the way CART 2 data were analyzed.
There was no comment Monday from Nissen in AtheroGenics' press release and he was missing from the company's conference call. But Dr. Jean Claude Tardif of Montreal Heart, the lead investigator in the CART 2 study, was supportive.
Here's how Herper handled the Nissen involvement in the Atherogenics trial
AtheroGenics first rose to prominence by touting AGI-1067 as a treatment for inflammation of the arteries. The small biotech rushed into its late-stage study, at a cost of more than $40 million, to try to prove the drug reduced heart attacks, strokes, deaths and surgical procedures.
"But the company badly handled its midstage data, eroding investors' trust. One study, called CART-2, was designed to show that AGI-1067 prevented the buildup of cholesterol plaque in the arteries, as measured by an ultrasound probe. For some reason, Medford and his team were troubled by the results.
AtheroGenics brought in a second scientist, Steven Nissen of the Cleveland Clinic, to do a new analysis of the data. Nissen's analysis seemed to show that the drug worked at clearing out artery plaque, but an analysis by Jean-Claude Tardif of the Montreal Heart Institute, who collected the ultrasound data, was inconclusive."
http://www.forbes.com/sciencesandmedicine/2007/03/19/atherogenics-cardiac-heart-biz-bizhealth-cx_mh_0319cardiac.html
As for Berenson who quoted Nissen and Psaty who was rebuked by NCI for scaring people about the cancer risks of calcium channel blockers, the failure to handle the difficulties about conducting randomized clinical trials with all the scans, blood samples, etc and then adding in a comparative element, well....par for the course. At least this garbage is now in the business section.
But all this speaks to is the pressure to sell papers rather than report on "boring" science.The Atherogenics data could use some re-analysis of subpopulations but when you are trying to be a blockbuster you try to be all things to all people and wind up showing no difference.
So in the end the real story is the limited value of randomized clinical trials in an era of personalized medicine. That's not sexy cause it's science and doesn't have good guys or bad guys or advance Nissen's career. But it's closer to the truth. Which is often boring.
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Another great example of what Hillary and Paul Krugman were, less than a year ago was the "best care anywhere", namely the VA. Here's Krugman about how great the VA is, particularly in terms of how much it cares about it's patients, the veterans of America:
The key to the V.A.’s success is its long-term relationship with its clients: veterans, once in the V.A. system, normally stay in it for life. This means that the V.A. can ... make much better use of information technology than other health care providers. ... which reduces both costs and medical errors. The long-term relationship ... also lets the V.A. save money by investing heavily in preventive medicine, an area in which the private sector — which makes money by treating the sick, not by keeping people healthy — has shown little interest.
The result is a system that achieves higher customer satisfaction than the private sector, higher quality of care by a number of measures and lower mortality rates — at much lower cost per patient."
http://select.nytimes.com/2006/09/04/opinion/04krugman.html?_r=1&hp&oref=slogin
Easy to get high marks when you are just screening healthy people and sending them away. But arguably you should rate a health care system for how it treats the whole person when they are sick and in distress. So on the heels of data showing that the VA formularies reduce life span and increase suffering, the Congressional Budget Office shows that returning vets are waiting longer for care they never get...
Here's Donna Shalala who co-chairs the federal task force reviewing care for Iraq vets:
"Without designated care coordinators to plan the best treatment path for new patients, an untold number ended up lost.
In addition, injured combatants must go through two antiquated disability assessments -- one by the military and one by the VA -- to determine what treatment options are available. This means that many are forced to jump through bureaucratic hoops that might not even get them to the right place, Dr. Shalala said.
"For veterans' families to give up everything just to coordinate this care themselves is fundamentally unfair," she said. "The process is too old-fashioned. It has nothing to do with modern medicine, and we ought to be embarrassed."
http://www.ama-assn.org/amednews/2007/12/03/gvsa1203.htm
Hey Paul, that gives "long term relationship" a whole new meaning. Sounds like single payer care to me. Krugman's response will likely be to blame Bush for not spending more. That won't wash. Spending on the VA has doubled under his administration. And spending more, as the UK and Canada health systems have shown, doesn't reduce waiting. Or insure that doctors can actually practice effective medicine instead of guideline driven drivel.
If Krugman and others really cared about vets and not ideology they would support the following reform: Giving vets the freedom they were fighting for in Iraq. Let them choose where to go for health care. If they can't get immediate care in the VA, give them cash to buy a policy with a health plan that will offer to do so.
Vets will die waiting for Congress and the VA to act.
The key to the V.A.’s success is its long-term relationship with its clients: veterans, once in the V.A. system, normally stay in it for life. This means that the V.A. can ... make much better use of information technology than other health care providers. ... which reduces both costs and medical errors. The long-term relationship ... also lets the V.A. save money by investing heavily in preventive medicine, an area in which the private sector — which makes money by treating the sick, not by keeping people healthy — has shown little interest.
The result is a system that achieves higher customer satisfaction than the private sector, higher quality of care by a number of measures and lower mortality rates — at much lower cost per patient."
http://select.nytimes.com/2006/09/04/opinion/04krugman.html?_r=1&hp&oref=slogin
Easy to get high marks when you are just screening healthy people and sending them away. But arguably you should rate a health care system for how it treats the whole person when they are sick and in distress. So on the heels of data showing that the VA formularies reduce life span and increase suffering, the Congressional Budget Office shows that returning vets are waiting longer for care they never get...
Here's Donna Shalala who co-chairs the federal task force reviewing care for Iraq vets:
"Without designated care coordinators to plan the best treatment path for new patients, an untold number ended up lost.
In addition, injured combatants must go through two antiquated disability assessments -- one by the military and one by the VA -- to determine what treatment options are available. This means that many are forced to jump through bureaucratic hoops that might not even get them to the right place, Dr. Shalala said.
"For veterans' families to give up everything just to coordinate this care themselves is fundamentally unfair," she said. "The process is too old-fashioned. It has nothing to do with modern medicine, and we ought to be embarrassed."
http://www.ama-assn.org/amednews/2007/12/03/gvsa1203.htm
Hey Paul, that gives "long term relationship" a whole new meaning. Sounds like single payer care to me. Krugman's response will likely be to blame Bush for not spending more. That won't wash. Spending on the VA has doubled under his administration. And spending more, as the UK and Canada health systems have shown, doesn't reduce waiting. Or insure that doctors can actually practice effective medicine instead of guideline driven drivel.
If Krugman and others really cared about vets and not ideology they would support the following reform: Giving vets the freedom they were fighting for in Iraq. Let them choose where to go for health care. If they can't get immediate care in the VA, give them cash to buy a policy with a health plan that will offer to do so.
Vets will die waiting for Congress and the VA to act.
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What’s the difference between “universal†health care and “government†health care?
The sad answer is that the first is a good political sound bite and the latter is not. The truth is that they’re the same thing -- and neither is “free.â€
There is no such thing as “health care from heaven.†Just ask the citizens of any nation in the EU or Canada. Better yet, ask Illinois’ Governor Rod Blagojevich whose plan for “free†and “universal†coverage in the Prairie State (designed to be funded via a very un-free $7.6 billion gross receipts tax on Illinois businesses) went down in flames in the state legislature 107-0 ... after the Governor came out against his own idea.
As the Wall Street Journal opined, “'Universal' government health care has once again returned as a political cause, with many Democrats believing it's the key to White House victory in 2008. They might want to study last week's news from Illinois, where Democratic Governor Rod Blagojevich's tax increase to finance health care became the political rout of the year."
Some candidates for the presidency are beginning to get the picture – others not so much. Here’s an article from the New York Times that points out the problems of sound-bite health care plans:
http://www.nytimes.com/2007/11/25/us/politics/25mass.html?_health&oref=slogin
There’s no such thing as a free lunch – or “free†health care.
The sad answer is that the first is a good political sound bite and the latter is not. The truth is that they’re the same thing -- and neither is “free.â€
There is no such thing as “health care from heaven.†Just ask the citizens of any nation in the EU or Canada. Better yet, ask Illinois’ Governor Rod Blagojevich whose plan for “free†and “universal†coverage in the Prairie State (designed to be funded via a very un-free $7.6 billion gross receipts tax on Illinois businesses) went down in flames in the state legislature 107-0 ... after the Governor came out against his own idea.
As the Wall Street Journal opined, “'Universal' government health care has once again returned as a political cause, with many Democrats believing it's the key to White House victory in 2008. They might want to study last week's news from Illinois, where Democratic Governor Rod Blagojevich's tax increase to finance health care became the political rout of the year."
Some candidates for the presidency are beginning to get the picture – others not so much. Here’s an article from the New York Times that points out the problems of sound-bite health care plans:
http://www.nytimes.com/2007/11/25/us/politics/25mass.html?_health&oref=slogin
There’s no such thing as a free lunch – or “free†health care.
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Harvey Bale (IFPMA) responds to a recent letter in The Lancet accusing some patient groups of conflict of interest.
Thai MoH's undeclared interest: its profit-making pharma operation
The letter published in the last edition of The Lancet under the title "WHO's web-based public hearings: hijacked by pharma?" expresses surprise that patient groups could advocate "pro-IP" views in internet submissions ahead of last week's WHO Inter Governmental Working Group. It goes on to imply this could only have happened because of the "pharmaceutical industry compromising patient advocacy groups".
If the authors of the paper seek to present this as an issue, it is because they are firmly on the "anti-IP" side of the IGWG debate, but the authors conclude their letter by declaring that they have no conflict of interest.
The first author listed is Suwit Wilbulpolprasert, who correctly presents himself as an employee of the Ministry of Health, Nonthaburi, Thailand. The Thai Ministry of Health owns the Government Pharmaceutical Organization (GPO), the role of which is to manufacture and import medicines and sell them for profit.(1) The GPO made a net profit of one billion baht ($30.8 million) on revenues of 5 billion baht ($154.1 million) in 2005, according to former deputy health minister Anuthin Charnveerakul.(2)
The compulsory licenses that the Thai MoH has issued in the last year allow the GPO to import and sell for profit generic copies of two antiretrovirals and one cardiovascular medicine still under patent. This move raised an international furor and the Thai MoH has so far refrained from implementing its publicly stated intention to implement further compulsory licenses. Any outcome of the WHO IGWG which endorses expanded use of compulsory licensing would support the Thai MoH in issuing more such licenses and so help GPO to increase its profit-making activities. Dr. Wilbulpolprasert's declaration of no conflict of interest does not hold up.
I declare the following interests: I head the international R&D-based pharmaceutical industry association, which believes that adequate intellectual property protection is an essential prerequisite for innovation in medicines and the improvement of global health outcomes. The R&D pharmaceutical industry also believes that patients' voices should be heard in discussions about health policy, and is prepared to contribute financially to help permit this, while accepting that patient groups are free to express their own opinions, even when these might be critical of the industry.
Yours sincerely,
Dr. Harvey Bale
Director General
International Federation of Pharmaceutical Manufacturers & Associations
For more on this issue, see our November 16th blog entry, "Compulsory Hypocrisy" here:
http://drugwonks.com/2007/11/compulsory_hypocrisy.html
As H.L. Mencken once said, when someone says it isn't about money, it's about money.
Thai MoH's undeclared interest: its profit-making pharma operation
The letter published in the last edition of The Lancet under the title "WHO's web-based public hearings: hijacked by pharma?" expresses surprise that patient groups could advocate "pro-IP" views in internet submissions ahead of last week's WHO Inter Governmental Working Group. It goes on to imply this could only have happened because of the "pharmaceutical industry compromising patient advocacy groups".
If the authors of the paper seek to present this as an issue, it is because they are firmly on the "anti-IP" side of the IGWG debate, but the authors conclude their letter by declaring that they have no conflict of interest.
The first author listed is Suwit Wilbulpolprasert, who correctly presents himself as an employee of the Ministry of Health, Nonthaburi, Thailand. The Thai Ministry of Health owns the Government Pharmaceutical Organization (GPO), the role of which is to manufacture and import medicines and sell them for profit.(1) The GPO made a net profit of one billion baht ($30.8 million) on revenues of 5 billion baht ($154.1 million) in 2005, according to former deputy health minister Anuthin Charnveerakul.(2)
The compulsory licenses that the Thai MoH has issued in the last year allow the GPO to import and sell for profit generic copies of two antiretrovirals and one cardiovascular medicine still under patent. This move raised an international furor and the Thai MoH has so far refrained from implementing its publicly stated intention to implement further compulsory licenses. Any outcome of the WHO IGWG which endorses expanded use of compulsory licensing would support the Thai MoH in issuing more such licenses and so help GPO to increase its profit-making activities. Dr. Wilbulpolprasert's declaration of no conflict of interest does not hold up.
I declare the following interests: I head the international R&D-based pharmaceutical industry association, which believes that adequate intellectual property protection is an essential prerequisite for innovation in medicines and the improvement of global health outcomes. The R&D pharmaceutical industry also believes that patients' voices should be heard in discussions about health policy, and is prepared to contribute financially to help permit this, while accepting that patient groups are free to express their own opinions, even when these might be critical of the industry.
Yours sincerely,
Dr. Harvey Bale
Director General
International Federation of Pharmaceutical Manufacturers & Associations
For more on this issue, see our November 16th blog entry, "Compulsory Hypocrisy" here:
http://drugwonks.com/2007/11/compulsory_hypocrisy.html
As H.L. Mencken once said, when someone says it isn't about money, it's about money.
According to CMS Chief Medical Officer Barry Straube, the possibility of simultaneous FDA and CMS evaluations of new devices is again under consideration by agency officials. Straube, who also directs the CMS Office of Clinical Standards and Quality, said his agency is working with FDA on a proposal for parallel review, which could be made public in the "relatively near future."
In 2005 FDA officials suggested that a Federal Register notice would soon outline a way for companies to request parallel reviews as a way to streamline the normally sequential marketing-approval and Medicare-coverage processes.
"We came very close to putting together a pilot project two years ago, but it kind of got put to the back burner for reasons I'm not even sure of," Straube said.
Involving CMS in premarket studies "is highly problematic," commented AEI's Scott Gottlieb, in part because CMS lacks expertise in clinical trial design. He also points out that Industry is worried that proprietary data, which FDA must by law protect, will not remain confidential if it is shared early on with CMS, which is subject to different disclosure mandates.
I may have been born at night – but not last night, Dr.Straube. This is a back door to cost effectiveness in the FDA review process, or at the least, that is what it will become if we allow the cost-effectiveness gang to have their way.
In 2005 FDA officials suggested that a Federal Register notice would soon outline a way for companies to request parallel reviews as a way to streamline the normally sequential marketing-approval and Medicare-coverage processes.
"We came very close to putting together a pilot project two years ago, but it kind of got put to the back burner for reasons I'm not even sure of," Straube said.
Involving CMS in premarket studies "is highly problematic," commented AEI's Scott Gottlieb, in part because CMS lacks expertise in clinical trial design. He also points out that Industry is worried that proprietary data, which FDA must by law protect, will not remain confidential if it is shared early on with CMS, which is subject to different disclosure mandates.
I may have been born at night – but not last night, Dr.Straube. This is a back door to cost effectiveness in the FDA review process, or at the least, that is what it will become if we allow the cost-effectiveness gang to have their way.
In today's era of medical miracles, why isn't there a drug to off-set the effects of L-Tryptophan? Let Henry Waxman stew over that one.
In the meantime, here's an FDA joke you can tell the relatives:
Pharmaceutical Executive #1: "Did you hear that we're working on a new drug that bestows immortality?"
Pharmaceutical Executive #2: "Yeah. Too bad it'll take the FDA forever to approve it."
Have a terrific holiday.
In the meantime, here's an FDA joke you can tell the relatives:
Pharmaceutical Executive #1: "Did you hear that we're working on a new drug that bestows immortality?"
Pharmaceutical Executive #2: "Yeah. Too bad it'll take the FDA forever to approve it."
Have a terrific holiday.
Yesterday, the Center for Medicine in the Pubic Interest (CMPI) and the Duke University Center for Research on Prospective Health Care hosted the second meeting of the Patient Centric Health Leadership Forum.
Yes, that’s patient-centric – the counterpoint to cost-based – health care.
The day was kicked off by Ralph Snyderman, Chancellor Emeritus, Duke University and Chair of the Patient Centric Leadership Forum. Dr. Snyderman made the day’s opening presentation forever memorable by making a crucial point...
... since we are all embracing the concept of a “sustainable planet,†we should understand that such a notion must begin with the essential consideration of a “sustainable individual.â€
And that means a focus on “Prospective Health†with five key components:
* Health risk assessment tools
* Therapeutic evaluation tools
* Aligned health care providers
* Aligned reimbursement systems
* Motivated consumers
Difficult to be sure. But as the great health care philosopher Kermit the Frog opined, “It isn’t easy being green.â€
Full transcripts of the meeting will be available shortly.
Yes, that’s patient-centric – the counterpoint to cost-based – health care.
The day was kicked off by Ralph Snyderman, Chancellor Emeritus, Duke University and Chair of the Patient Centric Leadership Forum. Dr. Snyderman made the day’s opening presentation forever memorable by making a crucial point...
... since we are all embracing the concept of a “sustainable planet,†we should understand that such a notion must begin with the essential consideration of a “sustainable individual.â€
And that means a focus on “Prospective Health†with five key components:
* Health risk assessment tools
* Therapeutic evaluation tools
* Aligned health care providers
* Aligned reimbursement systems
* Motivated consumers
Difficult to be sure. But as the great health care philosopher Kermit the Frog opined, “It isn’t easy being green.â€
Full transcripts of the meeting will be available shortly.
The nation’s largest healthcare payers are embracing the use of what is known as “comparative effectiveness,†a fancy term for essentially evaluating different therapies for a particular condition based on their costs and efficacy. The trend is a politically popular way to help reign in the cost for drugs, devices, and procedures. And the move reflects a broader focus on cost, rather than care that is taking place at all levels of the American healthcare system.
But it’s important to move beyond criticizing comparative effectiveness in its current form, and instead towards creating a policy roadmap for integrating technologies and science that is more patient-centric into comparative effectiveness thinking.
Much the like the U.S. Food and Drug Administration created the Critical Path Initiative to apply 21st-century science to accelerate the development of personalized medicine, another national goal should be to create a Critical Path Initiative to apply new approaches to data analysis and clinical insights to promote patient-centric healthcare.
Why? Because comparative effectiveness should reflect and measure individual response to treatment based on the combination of genetic, clinical, and demographic factors that indicate what keep people healthy, improve their health, or prevent disease. First steps have been taken. For example, the Department of Health and Human Services has invested in electronic patient records and genomics. Encouraging the Centers for Medicare & Medicaid Services to adopt the use of data that takes into account patient needs would complement such efforts.
The Patient-Centric Health Leadership Forum, a joint program of the Center for Medicine in the Public Interest and the Duke University Center for Research on Prospective Health Care, will shortly initiate a Critical Path for comparative effectiveness much as the FDA developed a Critical Path for drug approval and development.
Our goal is to develop proposals to modernize the information used in the evaluation of the value of treatments. Just as the key scientific insights guiding the FDA critical path program are genetic variations and biomedical informatics that predict and inform individual responses to treatment, our goal is to establish a science-based process that incorporates the knowledge and tools of personalized medicine in reimbursement decisions: true evidence-based, patient-centric medicine.
Here's the rest of the story as explained in a new article in The Journal of Life Sciences:
http://www.tjols.com/article-421.html
Perhaps the most urgent goal of our project will be to engage CMS in our enterprise and to encourage public health officials to embrace new kinds of evidence development, partnerships with industry, the FDA, National Institutes of Health, and the new Reagan-Udall Foundation to “harness the potential of bio-information to evaluate and predict safety, effectiveness, and the value of treatments for each patient.
But it’s important to move beyond criticizing comparative effectiveness in its current form, and instead towards creating a policy roadmap for integrating technologies and science that is more patient-centric into comparative effectiveness thinking.
Much the like the U.S. Food and Drug Administration created the Critical Path Initiative to apply 21st-century science to accelerate the development of personalized medicine, another national goal should be to create a Critical Path Initiative to apply new approaches to data analysis and clinical insights to promote patient-centric healthcare.
Why? Because comparative effectiveness should reflect and measure individual response to treatment based on the combination of genetic, clinical, and demographic factors that indicate what keep people healthy, improve their health, or prevent disease. First steps have been taken. For example, the Department of Health and Human Services has invested in electronic patient records and genomics. Encouraging the Centers for Medicare & Medicaid Services to adopt the use of data that takes into account patient needs would complement such efforts.
The Patient-Centric Health Leadership Forum, a joint program of the Center for Medicine in the Public Interest and the Duke University Center for Research on Prospective Health Care, will shortly initiate a Critical Path for comparative effectiveness much as the FDA developed a Critical Path for drug approval and development.
Our goal is to develop proposals to modernize the information used in the evaluation of the value of treatments. Just as the key scientific insights guiding the FDA critical path program are genetic variations and biomedical informatics that predict and inform individual responses to treatment, our goal is to establish a science-based process that incorporates the knowledge and tools of personalized medicine in reimbursement decisions: true evidence-based, patient-centric medicine.
Here's the rest of the story as explained in a new article in The Journal of Life Sciences:
http://www.tjols.com/article-421.html
Perhaps the most urgent goal of our project will be to engage CMS in our enterprise and to encourage public health officials to embrace new kinds of evidence development, partnerships with industry, the FDA, National Institutes of Health, and the new Reagan-Udall Foundation to “harness the potential of bio-information to evaluate and predict safety, effectiveness, and the value of treatments for each patient.
One in 10 people over 65 – or 5.6 million Americans – will have Alzheimer’s Disease by 2010. Without interventional therapy, the number of cases is expected to rise to 13.5 million by 2050. Currently available treatments for Alzheimer’s disease provide only temporary symptomatic relief and only for some patients, while therapies under FDA review may significantly delay or reverse the course of the disease.
On this subject, an excellent piece in today’s on-line edition of The Journal of Life Sciences. It’s titled, “No Silver Bullet†and points out that, just because we do not, as of yet, have a cure for Alzheimer’s Disease, does not mean that our increased and enhanced ability to diagnonse this scourge isn’t a significant leap forward.
Here’s a link to the article:
http://www.tjols.com/article-388.html
The author, April Lynch, is a staff writer at the San Jose Mercury News, focusing on health, medicine, biotech, genomics, and environmental investigations. She has also worked as the paper’s editor for science and health coverage. She is the author of a forthcoming book on genomic medicine
According to Lynch:
“Before people develop full-blown Alzheimer’s disease, they usually experience a condition called mild cognitive impairment, or MCI. The signs of MCI, such as minor memory loss, can be so subtle that many people miss them, or dismiss them as routine “senior moments†that come with aging. Alzheimer’s researchers say that A-beta deposits and damage are already well underway in these peoples’ brains. If more of them could be caught early, and the new drugs work at limiting brain destruction, doctors could start therapy before serious illness sets in.â€
For those following the War Againist Alzheimers, you may also want to read the recent CMPI report on the potential economic impact that new treatments for Alzheimer's disease could have on the U.S. economy. The study was sponsored by ACT-AD, a coalition of 49 national organizations seeking to accelerate development of potential cures and treatments for Alzheimer’s disease. The full report can be found here:
http://cmpi.org/reports.php
The fight against Alzheimer’s Disease is another clarion call for the expeditious pursuit of the Critical Path Initiative.
On this subject, an excellent piece in today’s on-line edition of The Journal of Life Sciences. It’s titled, “No Silver Bullet†and points out that, just because we do not, as of yet, have a cure for Alzheimer’s Disease, does not mean that our increased and enhanced ability to diagnonse this scourge isn’t a significant leap forward.
Here’s a link to the article:
http://www.tjols.com/article-388.html
The author, April Lynch, is a staff writer at the San Jose Mercury News, focusing on health, medicine, biotech, genomics, and environmental investigations. She has also worked as the paper’s editor for science and health coverage. She is the author of a forthcoming book on genomic medicine
According to Lynch:
“Before people develop full-blown Alzheimer’s disease, they usually experience a condition called mild cognitive impairment, or MCI. The signs of MCI, such as minor memory loss, can be so subtle that many people miss them, or dismiss them as routine “senior moments†that come with aging. Alzheimer’s researchers say that A-beta deposits and damage are already well underway in these peoples’ brains. If more of them could be caught early, and the new drugs work at limiting brain destruction, doctors could start therapy before serious illness sets in.â€
For those following the War Againist Alzheimers, you may also want to read the recent CMPI report on the potential economic impact that new treatments for Alzheimer's disease could have on the U.S. economy. The study was sponsored by ACT-AD, a coalition of 49 national organizations seeking to accelerate development of potential cures and treatments for Alzheimer’s disease. The full report can be found here:
http://cmpi.org/reports.php
The fight against Alzheimer’s Disease is another clarion call for the expeditious pursuit of the Critical Path Initiative.
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.
