Latest Drugwonks' Blog
MA Senate President Therese Murray wants to ban all gifts, grants and honoraria to physicians. You can go to jail and be fined $5000 for giving a talk sponsored by the biotech or drug company. Take a pen and go to the pen. Two years max.
All designed to control health care spending. So let's see. Drug spending is 11 percent of total health care dollars -- and is rising less rapidly than other expenditures -- and generic drug scrips are rising much more rapidly in every major chronic disease area. Yeah, criminalizing the private actions of MDs with respect to drug companies will really bring medical costs to a screeching halt.
I wonder what the conflict of interest police on the web think about that. Giddy with the thought of eager trial attorneys and regulatory agencies sticking it to Big Phrma...
And speaking of conflicts, which Sen. Murray made much of in introducing her bill, those who live in the Bay State might want to know that Murray is a key supporter of 40T which would allow people like her to appoint unelected special districts to take property and raise taxes for private development projects..
" Within the district, an appointed panel, handpicked by the developers, would replace many of the functions of elected municipal officials. They could raise taxes ("assessments") without regard to the constraints of Proposition 2 1/2. They could pass their own bylaws. A vote of their unelected panel would replace any requirement in Massachusetts law for a democratic vote of the people within the district. In effect, this bill creates new towns within towns in which democracy and public purpose are replaced by the rule of unelected officials with a profit motive.
Chapter 40T turns the concept of conflict of interest on its head because government powers would be blatantly exercised to enrich private parties. By evading democratic checks and balances, it offers unlimited opportunities for abuse."
http://www.masschc.org/chapter40T.html
No potential for conflict there.... I wonder who contributed to her campaign?
But watch the connect the dot crowd ignore the hypocrisy and double standards of the pols who want to put physicians on a watch list.
http://www.boston.com/news/local/articles/2008/03/04/ban_on_gifts_to_doctors_sought/
The conflict of interest movement is morphing into a lynch mob..
All designed to control health care spending. So let's see. Drug spending is 11 percent of total health care dollars -- and is rising less rapidly than other expenditures -- and generic drug scrips are rising much more rapidly in every major chronic disease area. Yeah, criminalizing the private actions of MDs with respect to drug companies will really bring medical costs to a screeching halt.
I wonder what the conflict of interest police on the web think about that. Giddy with the thought of eager trial attorneys and regulatory agencies sticking it to Big Phrma...
And speaking of conflicts, which Sen. Murray made much of in introducing her bill, those who live in the Bay State might want to know that Murray is a key supporter of 40T which would allow people like her to appoint unelected special districts to take property and raise taxes for private development projects..
" Within the district, an appointed panel, handpicked by the developers, would replace many of the functions of elected municipal officials. They could raise taxes ("assessments") without regard to the constraints of Proposition 2 1/2. They could pass their own bylaws. A vote of their unelected panel would replace any requirement in Massachusetts law for a democratic vote of the people within the district. In effect, this bill creates new towns within towns in which democracy and public purpose are replaced by the rule of unelected officials with a profit motive.
Chapter 40T turns the concept of conflict of interest on its head because government powers would be blatantly exercised to enrich private parties. By evading democratic checks and balances, it offers unlimited opportunities for abuse."
http://www.masschc.org/chapter40T.html
No potential for conflict there.... I wonder who contributed to her campaign?
But watch the connect the dot crowd ignore the hypocrisy and double standards of the pols who want to put physicians on a watch list.
http://www.boston.com/news/local/articles/2008/03/04/ban_on_gifts_to_doctors_sought/
The conflict of interest movement is morphing into a lynch mob..
Senators Baucus and Conrad have introduced the “The Comparative Effectiveness Research Act of 2008â€. It has all of the conflicts and biases towards cost containment that other similar entities have.
1. It is a clone of the UK National Institute for Clinical Excellence (NICE) NICE is independent and does not mandate coverage, guidelines or reimbursement. SImilarly CERA does not mandate coverage, reimbursement, or other
policies for any public or private payer. States that none of the reports or research
findings shall be construed as mandates, guidelines, or policy recommendations.
But NICE winds up being the de fault position for National Health Service in the UK. In fact, after NICE was instituted, the NHS made acceptance of their evaluations a requirement for reimbursement. Nothing in the bill stops CMS or a private insurer from imposing that requirement on patients and doctors. But it will happen.
2. NICE completely ignores the development of metrics and measures to capture patient variation at the genetic and biological level in assessing value and outcomes.
So doe CERA. For all Baucus' observation that the age of personalized medicine and genetic engineering will
provide even more choices for patients and their physicians there is nothing -- absolutely nothing in the bill that would stimulate the development of measures and studies that reflect such advances. How can patients make choices among treatment options developed from personalized medicine with evaluation techniques that ignore such variation?
3. The bias towards large randomized trials, review of old and small studies and sponsors that benefit from it are grandfathered into CERA. The bill directs the Institute to "give preference to federal agencies and instrumentalities
with experience in conducting comparative effectiveness research, such as the
Agency for Healthcare Research and Quality (ARHQ), when entering into
contracts for the management and conduct of research according to the research
project agenda. "
Guess who ARHQ relies on for such research? Entities funded by HMOs and other payers with a goal towards cost containment. And it defers to the NIH which has given us CATIE, ALLHAT and the clarity-inducing results of the ACCORD study on the effect of reducing insulin below existing target levels on stroke and other diabetes related illness. Yes, money well spent. And it defers to CMS as well with it's well documented effort to develop patient-centered approaches to anemia drug dosing instead of a one size fits all approach...
Moreover, CERA "allows the Institute to alternatively enter into contracts with appropriate private sector research or study-conducting entities for the conduct of research according to the research project agenda."
Here's a hint, it's not Phrma or BIO or any of the study conducting entities they support. Of course neither. Not that either would be a better or less self-serving job.
4. CERA presumes that comparative effectiveness research does improve outcomes or improve better quality evidence concerning the best treatment, prevention, and management of the health conditions. It assumes that comparative effectiveness research helps patients, providers, and payers of health care to make more informed decisions.
Is there any evidence that these two assumptions are true?
How about a study to determine whether comparative effectiveness research is, compared to other types of research, actually achieves these goals? At least a meta-analysis or review to examine just how well-designed or comparatively effective comparative effectiveness research is...
And what if CERA becomes a de facto guideline for reimbursement and coverage. Doesn't it become another obstacle to access, just like in the UK, CMS and health plans that try to deny cancer patients coverage to innovative uses of new medicines?
How about a study about that?
All the "stakeholders" in DC and beyond are acting like this is a fait accompli. Hardly. By the time this bill gets through hearings and proper vetting, it will not stand in it's current form or at all.
1. It is a clone of the UK National Institute for Clinical Excellence (NICE) NICE is independent and does not mandate coverage, guidelines or reimbursement. SImilarly CERA does not mandate coverage, reimbursement, or other
policies for any public or private payer. States that none of the reports or research
findings shall be construed as mandates, guidelines, or policy recommendations.
But NICE winds up being the de fault position for National Health Service in the UK. In fact, after NICE was instituted, the NHS made acceptance of their evaluations a requirement for reimbursement. Nothing in the bill stops CMS or a private insurer from imposing that requirement on patients and doctors. But it will happen.
2. NICE completely ignores the development of metrics and measures to capture patient variation at the genetic and biological level in assessing value and outcomes.
So doe CERA. For all Baucus' observation that the age of personalized medicine and genetic engineering will
provide even more choices for patients and their physicians there is nothing -- absolutely nothing in the bill that would stimulate the development of measures and studies that reflect such advances. How can patients make choices among treatment options developed from personalized medicine with evaluation techniques that ignore such variation?
3. The bias towards large randomized trials, review of old and small studies and sponsors that benefit from it are grandfathered into CERA. The bill directs the Institute to "give preference to federal agencies and instrumentalities
with experience in conducting comparative effectiveness research, such as the
Agency for Healthcare Research and Quality (ARHQ), when entering into
contracts for the management and conduct of research according to the research
project agenda. "
Guess who ARHQ relies on for such research? Entities funded by HMOs and other payers with a goal towards cost containment. And it defers to the NIH which has given us CATIE, ALLHAT and the clarity-inducing results of the ACCORD study on the effect of reducing insulin below existing target levels on stroke and other diabetes related illness. Yes, money well spent. And it defers to CMS as well with it's well documented effort to develop patient-centered approaches to anemia drug dosing instead of a one size fits all approach...
Moreover, CERA "allows the Institute to alternatively enter into contracts with appropriate private sector research or study-conducting entities for the conduct of research according to the research project agenda."
Here's a hint, it's not Phrma or BIO or any of the study conducting entities they support. Of course neither. Not that either would be a better or less self-serving job.
4. CERA presumes that comparative effectiveness research does improve outcomes or improve better quality evidence concerning the best treatment, prevention, and management of the health conditions. It assumes that comparative effectiveness research helps patients, providers, and payers of health care to make more informed decisions.
Is there any evidence that these two assumptions are true?
How about a study to determine whether comparative effectiveness research is, compared to other types of research, actually achieves these goals? At least a meta-analysis or review to examine just how well-designed or comparatively effective comparative effectiveness research is...
And what if CERA becomes a de facto guideline for reimbursement and coverage. Doesn't it become another obstacle to access, just like in the UK, CMS and health plans that try to deny cancer patients coverage to innovative uses of new medicines?
How about a study about that?
All the "stakeholders" in DC and beyond are acting like this is a fait accompli. Hardly. By the time this bill gets through hearings and proper vetting, it will not stand in it's current form or at all.
On the heels of my article discussing McCain's market-driven views on health comes his statement to the effect that credible scientists believe that vaccines cause autism.
I think McCain is misinformed and was responding to a question from a parent with autism who really believes in this crap.
If he clarifies on the basis of sound science it will be a one day story. If not, as the folks at http://overlawyered.com note, he will have stepped in it big time:
"The Republican candidate sticks his foot in it in a major way on a topic extensively covered here over the years (as well as at my other site). Writes Mark Kleiman: "the thimerosal-autism theory is as dead as phlogiston in respectable company. I'm not surprised that 'respectable company' excludes a few ambulance-chasing lawyers looking for deep pockets and a some emotionally devastated parents looking for someone to blame. But it's distressing — to use no stronger term — that the presumptive Republican nominee for President, rather than looking at the evidence, has chosen to side with the panic-spreaders and pander to the emotions of the panic victims."
My take. This was a well-meaning but less than informed statement. McCain is not the first Senator to know little about the complexities of this issue. Let's give the guy a couple of days to actually look at the evidence instead of being force fed foolishness from Dan Burton.
And PS. Autism cases have NOT increase as the Senator stated. Reclassification explains the surge in incidence and prevalence.
I think McCain is misinformed and was responding to a question from a parent with autism who really believes in this crap.
If he clarifies on the basis of sound science it will be a one day story. If not, as the folks at http://overlawyered.com note, he will have stepped in it big time:
"The Republican candidate sticks his foot in it in a major way on a topic extensively covered here over the years (as well as at my other site). Writes Mark Kleiman: "the thimerosal-autism theory is as dead as phlogiston in respectable company. I'm not surprised that 'respectable company' excludes a few ambulance-chasing lawyers looking for deep pockets and a some emotionally devastated parents looking for someone to blame. But it's distressing — to use no stronger term — that the presumptive Republican nominee for President, rather than looking at the evidence, has chosen to side with the panic-spreaders and pander to the emotions of the panic victims."
My take. This was a well-meaning but less than informed statement. McCain is not the first Senator to know little about the complexities of this issue. Let's give the guy a couple of days to actually look at the evidence instead of being force fed foolishness from Dan Burton.
And PS. Autism cases have NOT increase as the Senator stated. Reclassification explains the surge in incidence and prevalence.
We strongly support the free and fair sharing of legitimate scientific information. That's why we're in favor of both the use of reprints as an important way to share cutting-edge medical information with physicians and the FDA's draft rule on the appropriate ways to do so.
That being said, some organizations (notably those who publish medical journals) aren't quite so clear as to what they believe. In fact there seems to be a lot of "do as I say not as I do" going on these days.
Speaking about how pharmaceutical companies use medical journal reprints, here's what Catherine DeAngelis, MD -- editor-in-chief of the Journal of the American Medical Association -- said in yesterday's edition of the Newark Star-Ledger:
"I am really upset they would use these articles instead of seeking FDA approval for a new use," she said. "It's easier for them to take a drug they already have and get people to use it for something for which it has not been approved than it is to conduct new clinical trials."
Could this be the same JAMA that has a glossy sales brochure on the value of reprints -- many of which discuss off-label studies?
Some verbatim verbiage from the JAMA sales aid:
"Designed to be turn-key for rep delivery, mail, and distribution at conventions"
"Stimulates physician"
"Serves as an innovative, new offering for sales representatives and as a meeting premium"
The JAMA brochure goes on to quote (anonymously) some of its satisfied customers:
"I use them as a sales tool and patient education material."
"My accounts are refreshed by this type of promotional item because it shows that we have a genuine interest in patient needs and education."
JAMA also quotes research showing the efficacy of such reprints:
"38% of physicians cite pharmaceutical sales representatives as the most frequent source of providing patient education materials."
There's no qualifier about what articles can be reprinted. No caveat against reprints that include discussions of off-label usage -- however there is a strict rule that the full FDA PI must be included in every reprint package.
Nor is JAMA taking aesthetics for granted. The covers of these reprint programs can be customized from a selection of 10 Alfons Van Cleven paintings. My favorite is "Fall Landscape in Deer Grove" -- although for a reprint on Lyme Disease, perhaps "Winter Sunset" would be more appropriate.
Helpfully, the JAMA brochure points out that Van Cleven is an artist from the school known as "New Realism."
Yeah, New Realism. It must be Dr. DeAngelis' favorite.
There's a lot of that going around these days.
That being said, some organizations (notably those who publish medical journals) aren't quite so clear as to what they believe. In fact there seems to be a lot of "do as I say not as I do" going on these days.
Speaking about how pharmaceutical companies use medical journal reprints, here's what Catherine DeAngelis, MD -- editor-in-chief of the Journal of the American Medical Association -- said in yesterday's edition of the Newark Star-Ledger:
"I am really upset they would use these articles instead of seeking FDA approval for a new use," she said. "It's easier for them to take a drug they already have and get people to use it for something for which it has not been approved than it is to conduct new clinical trials."
Could this be the same JAMA that has a glossy sales brochure on the value of reprints -- many of which discuss off-label studies?
Some verbatim verbiage from the JAMA sales aid:
"Designed to be turn-key for rep delivery, mail, and distribution at conventions"
"Stimulates physician"
"Serves as an innovative, new offering for sales representatives and as a meeting premium"
The JAMA brochure goes on to quote (anonymously) some of its satisfied customers:
"I use them as a sales tool and patient education material."
"My accounts are refreshed by this type of promotional item because it shows that we have a genuine interest in patient needs and education."
JAMA also quotes research showing the efficacy of such reprints:
"38% of physicians cite pharmaceutical sales representatives as the most frequent source of providing patient education materials."
There's no qualifier about what articles can be reprinted. No caveat against reprints that include discussions of off-label usage -- however there is a strict rule that the full FDA PI must be included in every reprint package.
Nor is JAMA taking aesthetics for granted. The covers of these reprint programs can be customized from a selection of 10 Alfons Van Cleven paintings. My favorite is "Fall Landscape in Deer Grove" -- although for a reprint on Lyme Disease, perhaps "Winter Sunset" would be more appropriate.
Helpfully, the JAMA brochure points out that Van Cleven is an artist from the school known as "New Realism."
Yeah, New Realism. It must be Dr. DeAngelis' favorite.
There's a lot of that going around these days.
According to an article in the Connecticut Post:
"The federal government has a role in helping jump start the economy in the Naugatuck Valley, but much of that initiative needs to be done through a public/private partnership, U.S. Rep. Rosa DeLauro, D-3, told members of the Valley Chamber of Commerce this morning."
Representative DeLauro -- how about some support for another public/private partnership, one will help jump start 21st century health care -- the Reagan/Udall Foundation.
"The federal government has a role in helping jump start the economy in the Naugatuck Valley, but much of that initiative needs to be done through a public/private partnership, U.S. Rep. Rosa DeLauro, D-3, told members of the Valley Chamber of Commerce this morning."
Representative DeLauro -- how about some support for another public/private partnership, one will help jump start 21st century health care -- the Reagan/Udall Foundation.
Previously we commented on the WHO sending a team to Bangkok to discuss compulsory licensing in the broader context of TRIPS flexibiltiies ("WHO to WIPO: Having wonderful time. Glad you're not here").
Here's a link to those comments:
http://drugwonks.com/2008/02/who_to_wipo_having_wonderful_time_glad_youre_not_here.html
Well, the WHO has completed it's report -- and it's a doozy. Here's a link to the complete report:
Download file
To give you a hint as to the direction of the study, here are the final 14 words of the report:
"WHO supports measures which improve access to essential medicines, including application of TRIPS flexibilities."
And in the context of the report, "TRIPS flexibilities" means "compulsory licensing."
However, earlier in the report, the WHO team has a moment of cognitive lucidity. Consider this statement:
"A competitive marketplace is the best way to ensure low prices for medicines. Proper organization of the market and application of anti-trust (monopoly) laws should facilitate price competition."
But it's only a brief shining moment. Here's the end of that paragraph:
"However, if the pharmaceutical market is not competitive and/or there is a need to contain medicine prices, governments may choose to institute price controls."
This report is both a "how-to" guide for nations considering compulsory licensing and a WHO-ized papal dispensation for intellectual property theft.
What would John Calvin say?
Here's a link to those comments:
http://drugwonks.com/2008/02/who_to_wipo_having_wonderful_time_glad_youre_not_here.html
Well, the WHO has completed it's report -- and it's a doozy. Here's a link to the complete report:
Download file
To give you a hint as to the direction of the study, here are the final 14 words of the report:
"WHO supports measures which improve access to essential medicines, including application of TRIPS flexibilities."
And in the context of the report, "TRIPS flexibilities" means "compulsory licensing."
However, earlier in the report, the WHO team has a moment of cognitive lucidity. Consider this statement:
"A competitive marketplace is the best way to ensure low prices for medicines. Proper organization of the market and application of anti-trust (monopoly) laws should facilitate price competition."
But it's only a brief shining moment. Here's the end of that paragraph:
"However, if the pharmaceutical market is not competitive and/or there is a need to contain medicine prices, governments may choose to institute price controls."
This report is both a "how-to" guide for nations considering compulsory licensing and a WHO-ized papal dispensation for intellectual property theft.
What would John Calvin say?
According to a report in the International Herald Tribune (via the Associated Press), the recently appointed head of Thailand's Food and Drug Administration resigned Monday "amid controversy over the new government's plan to review a policy of overriding patents on several expensive cancer-fighting drugs."
Chatree Banchuen was named secretary general of the FDA last week, making him the government's chief negotiator with multinational drug companies over pricing and licensing terms.
Chatree said he decided to resign because he felt "uncomfortable with the politics," explaining that critics had brought up old, unproven allegations linking him to corruption in a computer procurement project in 2003. He called the allegations "politically motivated and
groundless," without elaborating.
Here's a link to the complete article:
http://www.iht.com/articles/ap/2008/03/03/asia/AS-GEN-Thailand-Drug-Patents.php
Whether it's "questionable" purchasing practices for computers or prescription medicines it all equals the same thing -- theft.
Chatree Banchuen was named secretary general of the FDA last week, making him the government's chief negotiator with multinational drug companies over pricing and licensing terms.
Chatree said he decided to resign because he felt "uncomfortable with the politics," explaining that critics had brought up old, unproven allegations linking him to corruption in a computer procurement project in 2003. He called the allegations "politically motivated and
groundless," without elaborating.
Here's a link to the complete article:
http://www.iht.com/articles/ap/2008/03/03/asia/AS-GEN-Thailand-Drug-Patents.php
Whether it's "questionable" purchasing practices for computers or prescription medicines it all equals the same thing -- theft.
Although HTAs seem not to have hit my home country yet, because of socialized medicine this appears generally without giving its name.
Recently, the head doctor and chief of oncology at the university hospital of Lund (south Sweden) caught headlines by stating that he had changed his mind about approving new cancer medicines, as results kept improving due to these new treatments. In this week’s issue of Dagens Medicin (a Swedish weekly for health care, www.dagensmedicin.se), he restates the budgetary implications of having recourse to the latest treatments : "If a new medicine with a proven impact on the current pathology exists, then most patients (…) will demand it, regardless of the therapeutic effect."
Indeed : so would most patients, and so would Dr. Rose. His concern is budgetary, both as head of a clinic and as a professional. And his reversed position is very positive ; but saying that, since the number of new treatments in oncology is increasing radically, the "equation is insoluble" mainly reflects that the concerns of socialized medicine (as is unfortunately the dominating feature in Sweden) carry greater weight than the number of patients cured.
This article from the Journal of Clinical Oncology (http://jco.ascopubs.org/cgi/content/full/26/1/6) reviews the most prominent results over the past 25 years. And Dr. Rose’s conclusion, after going through these is the right one : « This (…) makes it virtually medically undefendable not to treat patients with primary liver cancer or metastasizing kidney cell cancers. But in Sweden there is currently no connection between a possible treatment effect of new and costly medicines and the budgetary requirements of the concerned clinics. »
The defence rests.
Recently, the head doctor and chief of oncology at the university hospital of Lund (south Sweden) caught headlines by stating that he had changed his mind about approving new cancer medicines, as results kept improving due to these new treatments. In this week’s issue of Dagens Medicin (a Swedish weekly for health care, www.dagensmedicin.se), he restates the budgetary implications of having recourse to the latest treatments : "If a new medicine with a proven impact on the current pathology exists, then most patients (…) will demand it, regardless of the therapeutic effect."
Indeed : so would most patients, and so would Dr. Rose. His concern is budgetary, both as head of a clinic and as a professional. And his reversed position is very positive ; but saying that, since the number of new treatments in oncology is increasing radically, the "equation is insoluble" mainly reflects that the concerns of socialized medicine (as is unfortunately the dominating feature in Sweden) carry greater weight than the number of patients cured.
This article from the Journal of Clinical Oncology (http://jco.ascopubs.org/cgi/content/full/26/1/6) reviews the most prominent results over the past 25 years. And Dr. Rose’s conclusion, after going through these is the right one : « This (…) makes it virtually medically undefendable not to treat patients with primary liver cancer or metastasizing kidney cell cancers. But in Sweden there is currently no connection between a possible treatment effect of new and costly medicines and the budgetary requirements of the concerned clinics. »
The defence rests.
The Weekly Standard
The Real Reformer
McCain's superior prescription for health care.
by Robert Goldberg
03/10/2008, Volume 013, Issue 25
http://www.weeklystandard.com/Content/Public/Articles/000/000/014/818zqeqa.asp
John McCain's proposal for health care reform is more than a plan for making health care more affordable and for controlling costs through deregulation and market competition. It is also an attempt to restore independence and human dignity to patients. Both of his potential opponents in the fall presidential race speak only of extending the government's role in health care--a position supported in the main by large corporations, unions, and the managed-care lobbies. McCain's patient-centered position makes him--not Clinton or Obama--the force for change in health care.
McCain's plan is based around patient-centered initiatives that already have broad support among Republicans in Congress. They include letting people buy health insurance nationally instead of only from state-regulated firms; giving people the choice of purchasing coverage through cooperatives or other organizations (churches or civic groups, for example); expanding health savings accounts; and making health insurance portable by giving people tax credits of up to $5,000 per family to buy their own coverage instead of getting it through an employer.
His chief concern is for people to take ownership of their health care. McCain likes to note that "Ronald Reagan said nobody ever washed a rental car. And that's true in health insurance. If they're responsible for it, then they will take more care of it."
At the heart of McCain's proposals is his effort to allow veterans, particularly soldiers returning from Iraq with traumatic brain injury and mental illness, to get care anywhere rather than just through the Veterans Health Administration (VA): "America's veterans have fought for our freedom. We should give them freedom to choose to carry their VA dollars to a provider that gives them the timely care at high quality and in the best location."
What stirs McCain are stories like that of Sergeant Eric Edmundson who returned from Iraq unable to walk or talk after being hit by a roadside bomb. Edmundson was sent to a VA hospital in Richmond, Virginia, for rehabilitation care. After six months, doctors said he was in a permanent vegetative state and tried to send him to a nursing home where he would be discharged from the Army. But Edmundson's father found out that his son could use his GI vocational benefits (available only after he received VA care but also only if he remained in the service) to receive treatment at one of the world's leading traumatic brain injury (TBI) centers: the Rehabilitation Institute in Chicago. His father prevailed over VA objections. After six months of therapy at the Chicago center, Edmundson was able to talk and walked out of the rehab center under his own power.
The VA system that McCain is attacking is the starting point for the Democratic plans for universal health care. Both Hillary Clinton and Barack Obama want to expand the VA's electronic health care system to the rest of the country. Obama has promised to spend $50 billion on electronic health records based on the VA model. And Clinton likes to claim credit for that model, which she calls an astounding success:
We started during the Clinton administration to transition the VA system to a paperless system. .  .  . The VA is leading the way in reducing medical errors, improving patient safety, and delivering high quality care; now this is a lesson about what can be done when we have a plan. A plan that is evidence-based, a plan that uses what we know works, and a system that we can actually get to respond to that evidence-based planning.
In fact, as a government audit discovered, the VA's paperless system has created a huge bottleneck, losing track of 53,000 veterans.
Last year, Obama introduced legislation requiring the VA to treat each returning vet in 30 days. Yet, the VA already had such a requirement, and, according to internal VA audits, 25 percent of all vets wait more than 30 days for their first exam. Of the veterans kept waiting, 27 percent had serious service-connected disabilities, including amputations and chronic problems such as frequent panic attacks. Iraq war vets often have to wait six months for their first appointment.
In some VA hospitals, vets wait 18 months for surgeries--a record worse than Canada's or England's national health care systems. The VA's budget for its health care system has doubled since 2001, and Obama still proposes to give more money.
The differences between McCain and the Democratic candidates on health care boil down to freedom of choice. Clinton and Obama want in varying degrees to force Americans to enroll in health plans designed by the government and pay premiums set by the government. Companies that don't cover workers would be required to pay an additional tax to subsidize what amounts to Medicaid for all. If previous experience with S-chip is a guide, it will lead private firms to dump employees into government-run plans. Both Obama and Clinton would limit what drugs and services plans pay for to what the government deems "cost effective."
If you don't want government health care, you won't be able to set up a health savings account as they will be illegal. McCain would increase the opportunities for individuals to choose the care that's best for them by giving patients and doctors the dollars, information, and freedom to make medical decisions instead of a government agency.
Indeed, if Eric Edmundson's father had possessed the freedom to take his son to the best place for care instead of waiting for a bureaucrat's approval, his son would have been walking sooner. McCain's health care plan reflects his desire to make the medical system for vets embody the same freedom and dignity they fought for in Iraq. That's a powerful vision for reforming the whole health care system.
Robert Goldberg is the vice president of the Center for Medicine in the Public Interest.
© Copyright 2008, News Corporation, Weekly Standard, All Rights Reserved.
The Real Reformer
McCain's superior prescription for health care.
by Robert Goldberg
03/10/2008, Volume 013, Issue 25
http://www.weeklystandard.com/Content/Public/Articles/000/000/014/818zqeqa.asp
John McCain's proposal for health care reform is more than a plan for making health care more affordable and for controlling costs through deregulation and market competition. It is also an attempt to restore independence and human dignity to patients. Both of his potential opponents in the fall presidential race speak only of extending the government's role in health care--a position supported in the main by large corporations, unions, and the managed-care lobbies. McCain's patient-centered position makes him--not Clinton or Obama--the force for change in health care.
McCain's plan is based around patient-centered initiatives that already have broad support among Republicans in Congress. They include letting people buy health insurance nationally instead of only from state-regulated firms; giving people the choice of purchasing coverage through cooperatives or other organizations (churches or civic groups, for example); expanding health savings accounts; and making health insurance portable by giving people tax credits of up to $5,000 per family to buy their own coverage instead of getting it through an employer.
His chief concern is for people to take ownership of their health care. McCain likes to note that "Ronald Reagan said nobody ever washed a rental car. And that's true in health insurance. If they're responsible for it, then they will take more care of it."
At the heart of McCain's proposals is his effort to allow veterans, particularly soldiers returning from Iraq with traumatic brain injury and mental illness, to get care anywhere rather than just through the Veterans Health Administration (VA): "America's veterans have fought for our freedom. We should give them freedom to choose to carry their VA dollars to a provider that gives them the timely care at high quality and in the best location."
What stirs McCain are stories like that of Sergeant Eric Edmundson who returned from Iraq unable to walk or talk after being hit by a roadside bomb. Edmundson was sent to a VA hospital in Richmond, Virginia, for rehabilitation care. After six months, doctors said he was in a permanent vegetative state and tried to send him to a nursing home where he would be discharged from the Army. But Edmundson's father found out that his son could use his GI vocational benefits (available only after he received VA care but also only if he remained in the service) to receive treatment at one of the world's leading traumatic brain injury (TBI) centers: the Rehabilitation Institute in Chicago. His father prevailed over VA objections. After six months of therapy at the Chicago center, Edmundson was able to talk and walked out of the rehab center under his own power.
The VA system that McCain is attacking is the starting point for the Democratic plans for universal health care. Both Hillary Clinton and Barack Obama want to expand the VA's electronic health care system to the rest of the country. Obama has promised to spend $50 billion on electronic health records based on the VA model. And Clinton likes to claim credit for that model, which she calls an astounding success:
We started during the Clinton administration to transition the VA system to a paperless system. .  .  . The VA is leading the way in reducing medical errors, improving patient safety, and delivering high quality care; now this is a lesson about what can be done when we have a plan. A plan that is evidence-based, a plan that uses what we know works, and a system that we can actually get to respond to that evidence-based planning.
In fact, as a government audit discovered, the VA's paperless system has created a huge bottleneck, losing track of 53,000 veterans.
Last year, Obama introduced legislation requiring the VA to treat each returning vet in 30 days. Yet, the VA already had such a requirement, and, according to internal VA audits, 25 percent of all vets wait more than 30 days for their first exam. Of the veterans kept waiting, 27 percent had serious service-connected disabilities, including amputations and chronic problems such as frequent panic attacks. Iraq war vets often have to wait six months for their first appointment.
In some VA hospitals, vets wait 18 months for surgeries--a record worse than Canada's or England's national health care systems. The VA's budget for its health care system has doubled since 2001, and Obama still proposes to give more money.
The differences between McCain and the Democratic candidates on health care boil down to freedom of choice. Clinton and Obama want in varying degrees to force Americans to enroll in health plans designed by the government and pay premiums set by the government. Companies that don't cover workers would be required to pay an additional tax to subsidize what amounts to Medicaid for all. If previous experience with S-chip is a guide, it will lead private firms to dump employees into government-run plans. Both Obama and Clinton would limit what drugs and services plans pay for to what the government deems "cost effective."
If you don't want government health care, you won't be able to set up a health savings account as they will be illegal. McCain would increase the opportunities for individuals to choose the care that's best for them by giving patients and doctors the dollars, information, and freedom to make medical decisions instead of a government agency.
Indeed, if Eric Edmundson's father had possessed the freedom to take his son to the best place for care instead of waiting for a bureaucrat's approval, his son would have been walking sooner. McCain's health care plan reflects his desire to make the medical system for vets embody the same freedom and dignity they fought for in Iraq. That's a powerful vision for reforming the whole health care system.
Robert Goldberg is the vice president of the Center for Medicine in the Public Interest.
© Copyright 2008, News Corporation, Weekly Standard, All Rights Reserved.
Here is the second installment from our recent health care leadership forum on patient-centric medicine. These are the comments of Ralph Snyderman, M.D., recipient of the 2007 Leadership in Personalized Medicine Award from the Personalized Medicine Coalition.
Dr. Snyderman is Chancellor Emeritus at Duke University and former Chancellor for Health Affairs at Duke University, President and CEO of Duke University Health System and James B. Duke Professor of Medicine. He oversaw the development of the Duke University Health System, one of the few fully integrated academic health systems in the country. This integrated health system now provides an increasing continuum of care throughout North Carolina and beyond. Dr. Snyderman describes how the current health system is broken and how patient centric medicine could help repair it.
"We all recognize that the current healthcare system is broken. We’re spending $2.2 trillion a year, not on a healthcare system but a sick-care system that is highly inefficient.
Seventy-five cents of every healthcare dollar is spent for the acute treatment of generally late-stage chronic disease, which is often preventable.
The patient, of course, is in a quandary. I only know of two industries in which the consumer is given so little attention. One is the airline industry, which pretty much doesn’t care about the consumer. And, ironically, the healthcare system. The consumer is in there, but always as byproduct of all the technologies, the capabilities, that are being developed.
The likelihood of an individual developing a chronic disease is based on a number of things. Number one is their baseline inherited risk. That’s then modified by environmental or initiating events, exposure to things or various behaviors which may lead to preclinical progression, disease initiation. All of this develops over time, most often many years.
The irony is that as you wait, there tends to be an accumulation of disease burden. Once it becomes clinically manifest, and then there tends to be an inflection, a crescendo, in which things can get steadily worse in a series of acute events. Our current healthcare system is designed to focus on acute events. That’s where the cost is high and reversibility is low because there was a buildup of pathology.
Now the good news is that now we have powerful emerging technologies that are very producing powerful, and we’re developing important therapeutics, plus important diagnostics, including those that will enable personal clinical risk prediction,. Genomics, proteomics, metabolomics, new medical technologies, informatics and system biology, which is an approach to understanding the multiple networks of genes and metabolic systems, can all have a positive impact in empowering personalized health risk assessment..
We need to communicate that the power of these new technologies is allowing us to develop the capabilities of predicting risk in a much shorter time-frame and actually being able to predict risk across a person’s life. That’s a whole different approach to health care -- individualized risk prediction.
We’ll be able to measure what’s actually going on in a person’s circulation and tissues to determine if they are progressing along a disease pathway. It’s fairly clear that with risk prediction tools along with powerful digital imaging, metabolic imaging and other technologies, we can start to determine disease initiation and progression. We are going to get so much better with in being able to track development of problems very early on. Individuals are different. And where somebody might benefit from a thiazide diuretic, somebody else may be very badly harmed. We cannot assume that everybody will benefit from the same approaches or therapies.
We are beginning to understand that severe adverse outcomes can be predictable on a personalized basis, and the benefits of various therapies could be predicted at a personalized level.
A number of companies have sprung up to try to develop predictive tools for disease events, to personalize therapy. By studying a population of patients and outcomes, you can try to determine what individual factors helped predicted determine the outcome. Whether they be clinical data, genetic data, proteomic data, any other digital kind of information can be analyzed in clinical cohorts with the use of various types of biostatistical algorithms to come up with a predictive model. The power of these models is going to get better as we have more precise clinical data.
There is an emerging movement, what some people call P-4 Medicine or what I call prospective health care—personalized, predictive, preventative, and participatory. It would be personalized to the individual; predictive, so we could anticipate events before they occur, and then try to prevent them. The patient’s participation is a key feature. It’s hard to imagine a fix until we build this in, that people get invested in being more responsible for their own health.
For prospective healthcare to create an individual strategic health plan to for each patient, we need to develop these risk assessment and therapeutic evaluation tools. How is health care itself delivered to an individual over time? Our delivery system is designed for acute intervention that is not integrated and doesn’t provide continuity of care. The reimbursement system has a lot to do with that. Institutions can lose a lot of money trying to do the right thing in providing continuity of care.
At Duke, we have a prospective healthcare program where the participating population is university employees who get their care from Duke. They Duke is are essentially self-insured, so it’s one of those areas in which the reimbursement systems actually align. We have employees who stay with us very often for their entire professional lives. With the right tools, you can then, based on the chronic disease, divide the population into those that are low risk, high risk, early chronic disease, late chronic disease, and align the resources to the needs of the individual patient. So that in those individuals who may be high risk are given, we give them a lot of help in terms of risk modification, and allow helped them to develop their own strategic health plans. The general concept is to divide the population based on their specific risks and their health status and then give them access to the level of support they need.
The individual needs to play an active different role. We need to do something to raise the attention of the public of health as a value. One of the things that amuses me seems to be that over the last three to six months, virtually every major industry that contributes to environmental pollution has become green. Every oil company is green. General Motors is green. Everything is green to try to save the planet. Well, what about health? What about the individual? We talk about a sustainable planet, but what about a sustainable individual? We really need to get the appreciation of health as a value, similar to what we’re doing with the planet as a value."
Dr. Snyderman is Chancellor Emeritus at Duke University and former Chancellor for Health Affairs at Duke University, President and CEO of Duke University Health System and James B. Duke Professor of Medicine. He oversaw the development of the Duke University Health System, one of the few fully integrated academic health systems in the country. This integrated health system now provides an increasing continuum of care throughout North Carolina and beyond. Dr. Snyderman describes how the current health system is broken and how patient centric medicine could help repair it.
"We all recognize that the current healthcare system is broken. We’re spending $2.2 trillion a year, not on a healthcare system but a sick-care system that is highly inefficient.
Seventy-five cents of every healthcare dollar is spent for the acute treatment of generally late-stage chronic disease, which is often preventable.
The patient, of course, is in a quandary. I only know of two industries in which the consumer is given so little attention. One is the airline industry, which pretty much doesn’t care about the consumer. And, ironically, the healthcare system. The consumer is in there, but always as byproduct of all the technologies, the capabilities, that are being developed.
The likelihood of an individual developing a chronic disease is based on a number of things. Number one is their baseline inherited risk. That’s then modified by environmental or initiating events, exposure to things or various behaviors which may lead to preclinical progression, disease initiation. All of this develops over time, most often many years.
The irony is that as you wait, there tends to be an accumulation of disease burden. Once it becomes clinically manifest, and then there tends to be an inflection, a crescendo, in which things can get steadily worse in a series of acute events. Our current healthcare system is designed to focus on acute events. That’s where the cost is high and reversibility is low because there was a buildup of pathology.
Now the good news is that now we have powerful emerging technologies that are very producing powerful, and we’re developing important therapeutics, plus important diagnostics, including those that will enable personal clinical risk prediction,. Genomics, proteomics, metabolomics, new medical technologies, informatics and system biology, which is an approach to understanding the multiple networks of genes and metabolic systems, can all have a positive impact in empowering personalized health risk assessment..
We need to communicate that the power of these new technologies is allowing us to develop the capabilities of predicting risk in a much shorter time-frame and actually being able to predict risk across a person’s life. That’s a whole different approach to health care -- individualized risk prediction.
We’ll be able to measure what’s actually going on in a person’s circulation and tissues to determine if they are progressing along a disease pathway. It’s fairly clear that with risk prediction tools along with powerful digital imaging, metabolic imaging and other technologies, we can start to determine disease initiation and progression. We are going to get so much better with in being able to track development of problems very early on. Individuals are different. And where somebody might benefit from a thiazide diuretic, somebody else may be very badly harmed. We cannot assume that everybody will benefit from the same approaches or therapies.
We are beginning to understand that severe adverse outcomes can be predictable on a personalized basis, and the benefits of various therapies could be predicted at a personalized level.
A number of companies have sprung up to try to develop predictive tools for disease events, to personalize therapy. By studying a population of patients and outcomes, you can try to determine what individual factors helped predicted determine the outcome. Whether they be clinical data, genetic data, proteomic data, any other digital kind of information can be analyzed in clinical cohorts with the use of various types of biostatistical algorithms to come up with a predictive model. The power of these models is going to get better as we have more precise clinical data.
There is an emerging movement, what some people call P-4 Medicine or what I call prospective health care—personalized, predictive, preventative, and participatory. It would be personalized to the individual; predictive, so we could anticipate events before they occur, and then try to prevent them. The patient’s participation is a key feature. It’s hard to imagine a fix until we build this in, that people get invested in being more responsible for their own health.
For prospective healthcare to create an individual strategic health plan to for each patient, we need to develop these risk assessment and therapeutic evaluation tools. How is health care itself delivered to an individual over time? Our delivery system is designed for acute intervention that is not integrated and doesn’t provide continuity of care. The reimbursement system has a lot to do with that. Institutions can lose a lot of money trying to do the right thing in providing continuity of care.
At Duke, we have a prospective healthcare program where the participating population is university employees who get their care from Duke. They Duke is are essentially self-insured, so it’s one of those areas in which the reimbursement systems actually align. We have employees who stay with us very often for their entire professional lives. With the right tools, you can then, based on the chronic disease, divide the population into those that are low risk, high risk, early chronic disease, late chronic disease, and align the resources to the needs of the individual patient. So that in those individuals who may be high risk are given, we give them a lot of help in terms of risk modification, and allow helped them to develop their own strategic health plans. The general concept is to divide the population based on their specific risks and their health status and then give them access to the level of support they need.
The individual needs to play an active different role. We need to do something to raise the attention of the public of health as a value. One of the things that amuses me seems to be that over the last three to six months, virtually every major industry that contributes to environmental pollution has become green. Every oil company is green. General Motors is green. Everything is green to try to save the planet. Well, what about health? What about the individual? We talk about a sustainable planet, but what about a sustainable individual? We really need to get the appreciation of health as a value, similar to what we’re doing with the planet as a value."
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.
