Latest Drugwonks' Blog
Ok to rate doctors and hospitals, but why are HMOs so reluctant to be rated in terms of how patient-centered they are? Blue Cross, Zagat to rank doctors
Blue Cross, Zagat to rank doctors
But the ratings will be based on nonmedical factors, and some question insurance link
- Staff Writer
http://www.newsobserver.com/business/story/1342375.html
http://www.newsobserver.com/business/story/1342375.html
Could you invent better timing for a new book on integrated cardiac safety?
Our friend Rick Turner (along with Todd Durham) has co-authored an important new study of new, more effective approaches for screening drugs for adverse cardiac effects, "Integrated Cardiac Safety."
This timely tome deals with drugs that are not indicated for cardiac diseases or conditions. It begins with an introduction to cardiac safety assessment and the biology of adverse drug interactions. Following sections on cardiac function and cardiac pathophysiology and disease, the authors guide readers through the assessment process during discovery, pre-approval (including QT/QTc trials), and postmarketing surveillance. The book concludes with chapters on medication errors and an examination of future trends in drug safety.
For more information on this publication and how to order your own copy, see here.
The perfect holiday gift for the pharmacovigilance geek in your family!
Our friend Rick Turner (along with Todd Durham) has co-authored an important new study of new, more effective approaches for screening drugs for adverse cardiac effects, "Integrated Cardiac Safety."
This timely tome deals with drugs that are not indicated for cardiac diseases or conditions. It begins with an introduction to cardiac safety assessment and the biology of adverse drug interactions. Following sections on cardiac function and cardiac pathophysiology and disease, the authors guide readers through the assessment process during discovery, pre-approval (including QT/QTc trials), and postmarketing surveillance. The book concludes with chapters on medication errors and an examination of future trends in drug safety.
For more information on this publication and how to order your own copy, see here.
The perfect holiday gift for the pharmacovigilance geek in your family!
Desperate times call for desperate measures -- and nowhere is this more evident than in Governor Patterson's proposed budget for New York.
But pennywise and pound-foolish doesn't help. And nowhere is this more true than when it comes to healthcare.
Specifically, the Governor's budget calls for the required use of step therapy for many medications. This means patients must "fail" their way to more expensive (generally on-patent) drugs. So, even if a physician wants her patient on (what in her expert medical judgment is) the best, most effective therapy -- the state demands multiple therapeutic failures via less expensive options first. This is a short-term fix with very expensive long-term repercussions when you consider that (nationally) 7% of our healthcare spend is on brand-name pharmaceuticals while in excess of 30% is on hospital care. When patients are forced to fail -- hospitalization often ensures. The budget wizards in Albany calculate this program would save the state $18.9 million in the next budget year. But the unintended consequence of increased hospitalization rates could be staggering. Step therapy? Bad idea.
Another codicil calls for required disclosure of payments by manufacturers to prescribers of over $50. There is no listed budgetary saving to the state. So why is it in the budget? We know why -- because too many of our elected representatives have a serious jones out for the pharmaceutical industry. So be it. But if disclosure is the order of the day than it should also be required of insurance companies that offer monetary spiffs to physicians for switching their patients to lower cost medicines and to lawyers who pay doctors to be "expert" witnesses. What's good for the goose is good for the gander -- but it doesn't save the state a nickel.
Along these same lines is another line item that requires the presenters of continuing medical education to disclose financial relationships with manufacturers. This is a contentious public policy issue -- but not a budgetary one. (For more on the CME issue, see "Battling the COI Polloi" here.) Savings to the citizens of New York State -- zero.
If the order of the day is austerity (and it is) then Albany needs to stay on point.
But pennywise and pound-foolish doesn't help. And nowhere is this more true than when it comes to healthcare.
Specifically, the Governor's budget calls for the required use of step therapy for many medications. This means patients must "fail" their way to more expensive (generally on-patent) drugs. So, even if a physician wants her patient on (what in her expert medical judgment is) the best, most effective therapy -- the state demands multiple therapeutic failures via less expensive options first. This is a short-term fix with very expensive long-term repercussions when you consider that (nationally) 7% of our healthcare spend is on brand-name pharmaceuticals while in excess of 30% is on hospital care. When patients are forced to fail -- hospitalization often ensures. The budget wizards in Albany calculate this program would save the state $18.9 million in the next budget year. But the unintended consequence of increased hospitalization rates could be staggering. Step therapy? Bad idea.
Another codicil calls for required disclosure of payments by manufacturers to prescribers of over $50. There is no listed budgetary saving to the state. So why is it in the budget? We know why -- because too many of our elected representatives have a serious jones out for the pharmaceutical industry. So be it. But if disclosure is the order of the day than it should also be required of insurance companies that offer monetary spiffs to physicians for switching their patients to lower cost medicines and to lawyers who pay doctors to be "expert" witnesses. What's good for the goose is good for the gander -- but it doesn't save the state a nickel.
Along these same lines is another line item that requires the presenters of continuing medical education to disclose financial relationships with manufacturers. This is a contentious public policy issue -- but not a budgetary one. (For more on the CME issue, see "Battling the COI Polloi" here.) Savings to the citizens of New York State -- zero.
If the order of the day is austerity (and it is) then Albany needs to stay on point.
Playing FDA parlor games may be fun for some -- but reform of the U.S. Food and Drug Administration must be about serving the public health—not partisan political interests. That’s why I was honored when the Obama FDA transition team called and asked for my advice on how the incoming administration could make the agency a more robust and forward-looking regulatory instrument.
The transition team’s initial request was a memo, of no more than two pages, outlining key issues and offering general recommendations. Never have two pages seemed so inadequate. But I did my best.
My suggested areas of focus are
(1) A strong, science-based FDA
(2) The Reagan/Udall Foundation -- a Partnership of Unequals
(3) Clarity vs. Ambiguity
(4) Information Management
(5) Food Safety and Security
(6) Risk Communications
(7) The Drug Label and the "Safe Use" of Drugs
My complete memo to the transition team can be found here.
There are, obviously, many, many other important issues (a more thoughtful position on expanded access, United States-European Union regulatory harmonization, etc.) andI look forward to working with the transition team to ensure that the new commissioner can hit the ground running—in the right direction—with some early and important wins that will set the tone for a newly confident FDA. And kudos to the Obama transition team for reaching out to a wide variety of groups. That's the right way to get things done -- despite what some politicians and pundits may think.
The transition team’s initial request was a memo, of no more than two pages, outlining key issues and offering general recommendations. Never have two pages seemed so inadequate. But I did my best.
My suggested areas of focus are
(1) A strong, science-based FDA
(2) The Reagan/Udall Foundation -- a Partnership of Unequals
(3) Clarity vs. Ambiguity
(4) Information Management
(5) Food Safety and Security
(6) Risk Communications
(7) The Drug Label and the "Safe Use" of Drugs
My complete memo to the transition team can be found here.
There are, obviously, many, many other important issues (a more thoughtful position on expanded access, United States-European Union regulatory harmonization, etc.) andI look forward to working with the transition team to ensure that the new commissioner can hit the ground running—in the right direction—with some early and important wins that will set the tone for a newly confident FDA. And kudos to the Obama transition team for reaching out to a wide variety of groups. That's the right way to get things done -- despite what some politicians and pundits may think.
Steve Pearson is quoted in today's New York Times as filling in the evidence gap prostate cancer care... Wow.
“Most policy makers think that, in general, we would want to do more national coverage decisions, partly because there’s a concern that the evidence review in most local regions isn’t very good,” said Dr. Steven D. Pearson. He is president of the Institute for Clinical and Economic Review, an organization partly financed by the insurance industry that is pushing for the use of evidence in medical decisions.
But that concern reflects an impatience with the views of others, particularly patients and physicians who would disagree with comparative effectiveness decisions that Pearson and his group would be entitled to produce under proposed comparative effectiveness legislation. His response to to a piece by Tom Philipson in health affairs about how comparative effectiveness analysis is, in fact, price controls is revealing:
"Surely an innovation that creates a near-cure for HIV should be valued more than a new combination pill of previously established drugs. It seems nonsensical that society would want to lavish rewards on innovators who produce equivocal or marginal gains and charge a steep price. The key is not to control prices but to incentivize investment in interventions that yield significant gains in effectiveness. When used rigorously and transparently, cost-effec-tiveness criteria can send the signal that the bestway to succeed as an innovator is to create interventions that are much more effective than previous alternatives. This is the signal that is missing from much of the U.S. healthcare system, where low-risk and marginally superior interventions are marketed to price insensitive physicians and patients.
I would completely reframe the authors’ argument by advocating that linking insurance coverage to cost-effectiveness might make patients feel a little worse off today but would
greatly benefit future patientswho will inherit a less bloated and wasteful health care system. That way, future patients will find a health care market dominated by focused, skilled innovators
who know that their greatest reward will come from producing interventions of greatly enhanced effectiveness at a reasonable cost. If, as a result, some of today’s venture capital chooses to flee elsewhere to seek easier returns, so be it. Let’s get the innovation we want."
Note how he concludes that government set criteria or criteria provided by the institute via government contracts can replace "price insensitive physicians and patients." Then and only then my friends will be the innovation "we" want. And if we make patients a little worse off in the process, oh well.
“Most policy makers think that, in general, we would want to do more national coverage decisions, partly because there’s a concern that the evidence review in most local regions isn’t very good,” said Dr. Steven D. Pearson. He is president of the Institute for Clinical and Economic Review, an organization partly financed by the insurance industry that is pushing for the use of evidence in medical decisions.
But that concern reflects an impatience with the views of others, particularly patients and physicians who would disagree with comparative effectiveness decisions that Pearson and his group would be entitled to produce under proposed comparative effectiveness legislation. His response to to a piece by Tom Philipson in health affairs about how comparative effectiveness analysis is, in fact, price controls is revealing:
"Surely an innovation that creates a near-cure for HIV should be valued more than a new combination pill of previously established drugs. It seems nonsensical that society would want to lavish rewards on innovators who produce equivocal or marginal gains and charge a steep price. The key is not to control prices but to incentivize investment in interventions that yield significant gains in effectiveness. When used rigorously and transparently, cost-effec-tiveness criteria can send the signal that the bestway to succeed as an innovator is to create interventions that are much more effective than previous alternatives. This is the signal that is missing from much of the U.S. healthcare system, where low-risk and marginally superior interventions are marketed to price insensitive physicians and patients.
I would completely reframe the authors’ argument by advocating that linking insurance coverage to cost-effectiveness might make patients feel a little worse off today but would
greatly benefit future patientswho will inherit a less bloated and wasteful health care system. That way, future patients will find a health care market dominated by focused, skilled innovators
who know that their greatest reward will come from producing interventions of greatly enhanced effectiveness at a reasonable cost. If, as a result, some of today’s venture capital chooses to flee elsewhere to seek easier returns, so be it. Let’s get the innovation we want."
Note how he concludes that government set criteria or criteria provided by the institute via government contracts can replace "price insensitive physicians and patients." Then and only then my friends will be the innovation "we" want. And if we make patients a little worse off in the process, oh well.
Here's how Fred Scherer explains how price controls won't discourage innovation:
In criticizing a paper, one of only dozens showing that price controls do discourage innovation (and he only has to look at the reality in Europe, UK, and elswhere, but ok, just pretend your Harvard generated model is the real world ) Scherer claims "that the drugs chosen for the authors' analysis are neither the most therapeutically innovative candidates nor those whose development is most likely to be discouraged by price controls."
Really. So Prof. Scherer knows which drugs -- years before they will be approved and used and then subsequently evaluated with tomorrow's genomic and epigenetic techniques, which drugs will be the most therapeutically innovative or discouraged.
Has he run a drug or biotech company? How about a venture capital fund? Last time I checked, the most therapeutically innovative candidates were also the most challenging to develop and required a higher burn rate and a higher rate of return. And where is that money going to come from? Did he factor comparative effectiveness delays and market restrictions into his model?
See the Health Affairs article here.
In criticizing a paper, one of only dozens showing that price controls do discourage innovation (and he only has to look at the reality in Europe, UK, and elswhere, but ok, just pretend your Harvard generated model is the real world ) Scherer claims "that the drugs chosen for the authors' analysis are neither the most therapeutically innovative candidates nor those whose development is most likely to be discouraged by price controls."
Really. So Prof. Scherer knows which drugs -- years before they will be approved and used and then subsequently evaluated with tomorrow's genomic and epigenetic techniques, which drugs will be the most therapeutically innovative or discouraged.
Has he run a drug or biotech company? How about a venture capital fund? Last time I checked, the most therapeutically innovative candidates were also the most challenging to develop and required a higher burn rate and a higher rate of return. And where is that money going to come from? Did he factor comparative effectiveness delays and market restrictions into his model?
See the Health Affairs article here.
When news articles (as opposed to op-eds) offer opinions, they are supposed to be between quotation marks.
When a reporter slips in his own opinion, it’s sloppy editing at best and inappropriate bias at worst. Consider this paragraph of unattributed reportage from today’s New York Times article, “F.D.A. Commissioner and Other Top Health Officials Plan to Step Down” --
“If Dr. Sharfstein or Dr. Nissen is chosen, the selection is likely to signal the end of an era at the agency in which the speed of the drug approval process often took priority over the certainty of a drug’s safety.”
FDA has put speed of approval over safety? Says who? The New York Times? If that’s the opinion of the editorial page, then they should say so. If this is Gardiner Harris’ opinion, he’s entitled to it – personally, but this isn't where it belongs. Not ever.
Also, what’s all this about “certainty of a drug’s safety.” Is the New York Times calling for a Precautionary Principle approach to drug regulation?
When a reporter slips in his own opinion, it’s sloppy editing at best and inappropriate bias at worst. Consider this paragraph of unattributed reportage from today’s New York Times article, “F.D.A. Commissioner and Other Top Health Officials Plan to Step Down” --
“If Dr. Sharfstein or Dr. Nissen is chosen, the selection is likely to signal the end of an era at the agency in which the speed of the drug approval process often took priority over the certainty of a drug’s safety.”
FDA has put speed of approval over safety? Says who? The New York Times? If that’s the opinion of the editorial page, then they should say so. If this is Gardiner Harris’ opinion, he’s entitled to it – personally, but this isn't where it belongs. Not ever.
Also, what’s all this about “certainty of a drug’s safety.” Is the New York Times calling for a Precautionary Principle approach to drug regulation?
Do I sense a growing social consensus around the concept of collaborative healthcare reform? I do.
And that’s a good thing – because real reform cannot happen otherwise. Top-down efforts don’t cut it. That’s a lesson we can learn from our transatlantic cousins. Consider “High Quality Care for All,” (aka, “the Darzi report”) -- the recently released NHS “next stage review” document. It calls for, as one of its “key steps,” “ A Coalition for Better Health, with a set of new voluntary agreements between the Government, private and third sector organisations on actions to improve health outcomes.”
Jolly good -- and something our new healthcare czar/HHS Secretary should consider.
(If you’re interested in reading where the NHS is going – or at least planning to, here’s a link to the complete Darzi Report.)
Among other things, this means all stakeholders must have a seat at the table. Yes, even industry. And this has particular resonance when it comes to FDA and the Critical Path initiative. What we need is a consensus (especially among members of Congress like Representative Rosa DeLauro) that the agency can and indeed must be both regulator and colleague -- and that collaboration on developing the tools for 21st century drug development and regulatory science are too important to remain mired in the treacle of politics and posturing.
But there’s a caveat – all too familiar to our friends at the NHS -- that of using the costs of sickness “as a means of turning benevolence to power.”
That last quote comes from Paul Starr’s “The Social Transformation of American Medicine,” and it’s worth quoting in its entirety:
“Whoever provides medical care or pays the cost of illness stands to gain the gratitude and good will of the sick and their families. The prospect of these good-will returns to the investment in healthcare creates a powerful motive for government and other institutions to intervene in the economics of medicine. Political leaders since Bismarck seeking to strengthen the state or to advance their own or their party’s interests have used insurance against the costs of sickness as a means of turning benevolence to power.”
In other words, healthcare reform must be about healthcare – and not politics. Easier said than done? Certainly. But a truth we must, er, hold self-evident.
And that’s a good thing – because real reform cannot happen otherwise. Top-down efforts don’t cut it. That’s a lesson we can learn from our transatlantic cousins. Consider “High Quality Care for All,” (aka, “the Darzi report”) -- the recently released NHS “next stage review” document. It calls for, as one of its “key steps,” “ A Coalition for Better Health, with a set of new voluntary agreements between the Government, private and third sector organisations on actions to improve health outcomes.”
Jolly good -- and something our new healthcare czar/HHS Secretary should consider.
(If you’re interested in reading where the NHS is going – or at least planning to, here’s a link to the complete Darzi Report.)
Among other things, this means all stakeholders must have a seat at the table. Yes, even industry. And this has particular resonance when it comes to FDA and the Critical Path initiative. What we need is a consensus (especially among members of Congress like Representative Rosa DeLauro) that the agency can and indeed must be both regulator and colleague -- and that collaboration on developing the tools for 21st century drug development and regulatory science are too important to remain mired in the treacle of politics and posturing.
But there’s a caveat – all too familiar to our friends at the NHS -- that of using the costs of sickness “as a means of turning benevolence to power.”
That last quote comes from Paul Starr’s “The Social Transformation of American Medicine,” and it’s worth quoting in its entirety:
“Whoever provides medical care or pays the cost of illness stands to gain the gratitude and good will of the sick and their families. The prospect of these good-will returns to the investment in healthcare creates a powerful motive for government and other institutions to intervene in the economics of medicine. Political leaders since Bismarck seeking to strengthen the state or to advance their own or their party’s interests have used insurance against the costs of sickness as a means of turning benevolence to power.”
In other words, healthcare reform must be about healthcare – and not politics. Easier said than done? Certainly. But a truth we must, er, hold self-evident.
Healthcare "like in Europe?" Bad idea.
According to new study (published in a five-paper special report on drug pricing in Health Affairs), imposing European-style price controls on prescription drugs in the United States would result in modest cost savings that would be more than offset by shortened life spans as the pace of drug innovation slows.
The report suggests that lowering insurance co-payments would be a better way of attacking the problem of rising prescription drug prices in the United States.
"We found policies that regulate the prices of drugs could result in modest savings for consumers, in the best cases on the order of $5,000 to $10,000 per person over a lifetime," said Darius Lakdawalla of the nonprofit Rand Corporation. (This paper was funded by a grant from Pfizer and the National Institute on Aging.)
Lakdawalla and colleagues used computer models of price regulation in 19 countries to simulate the impact of price controls that cut drug company revenues by 20 percent.
They said introducing price regulations into a largely unregulated market like the United States would result in less investment in developing life-saving drugs, which in the long run would reduce the life expectancy of Americans.
"We found longevity declines on the order of about a half of year for people at the age of 55 when you look out to people who are alive in 2050 and 2060," he said.
A team of researchers that included Harvard economist David Cutler, a health policy adviser for President-elect Barack Obama, suggested in the same journal that drug spending growth rates had reached a "turning point."
They noted that while drug prices tripled from 1997 through 2007, spending in 2007 grew just 1.6 percent, the slowest rate since 1974, as many brand-name drugs lose patent protection.
Cutler and colleagues noted that prescription drug spending trends have changed dramatically in the past five years, and assumptions based on older trends no longer apply.
The Health Affairs special issue can be found here.
And Reuters coverage can be found here.
According to new study (published in a five-paper special report on drug pricing in Health Affairs), imposing European-style price controls on prescription drugs in the United States would result in modest cost savings that would be more than offset by shortened life spans as the pace of drug innovation slows.
The report suggests that lowering insurance co-payments would be a better way of attacking the problem of rising prescription drug prices in the United States.
"We found policies that regulate the prices of drugs could result in modest savings for consumers, in the best cases on the order of $5,000 to $10,000 per person over a lifetime," said Darius Lakdawalla of the nonprofit Rand Corporation. (This paper was funded by a grant from Pfizer and the National Institute on Aging.)
Lakdawalla and colleagues used computer models of price regulation in 19 countries to simulate the impact of price controls that cut drug company revenues by 20 percent.
They said introducing price regulations into a largely unregulated market like the United States would result in less investment in developing life-saving drugs, which in the long run would reduce the life expectancy of Americans.
"We found longevity declines on the order of about a half of year for people at the age of 55 when you look out to people who are alive in 2050 and 2060," he said.
A team of researchers that included Harvard economist David Cutler, a health policy adviser for President-elect Barack Obama, suggested in the same journal that drug spending growth rates had reached a "turning point."
They noted that while drug prices tripled from 1997 through 2007, spending in 2007 grew just 1.6 percent, the slowest rate since 1974, as many brand-name drugs lose patent protection.
Cutler and colleagues noted that prescription drug spending trends have changed dramatically in the past five years, and assumptions based on older trends no longer apply.
The Health Affairs special issue can be found here.
And Reuters coverage can be found here.
Another sign that we have gone crazy...
Now who will track the kids who die because they don't get the meds they need or turn to alternative treatments or OTC products? At least following the signal and figuring out the source would have been more rational and compassionate...
I found this post from FiercePharma said it best...
1. Why don't you add the web address where the public can comment to the FDA?
2.How DARE this eletist godlike panel decide what legal drugs I am allowed to take for my asthma.
It is MY choice if the short term benefit of a LABA is worth the long term potential risk.
3. I am allergic to Advair (unable to digest the lactose based carrier), to get the LABA & steroid I have to take them separately.
The god damned FDA Panel has no right to limit or deny me this legal medicine that can save my life.
The FDA panel should NOT make decisions about how to deliver the drugs (separately or together.) If the LABA is legal in Advair, then it is legal. Denying the use in other (competitive) medicines is dicriminatory, increases the risks to my life, and raises the prices. It is also illegal for Advair to have a monopoly- even if the FDA created it.
FDA panel votes down two asthma meds
See Full StoryNow who will track the kids who die because they don't get the meds they need or turn to alternative treatments or OTC products? At least following the signal and figuring out the source would have been more rational and compassionate...
I found this post from FiercePharma said it best...
1. Why don't you add the web address where the public can comment to the FDA?
2.How DARE this eletist godlike panel decide what legal drugs I am allowed to take for my asthma.
It is MY choice if the short term benefit of a LABA is worth the long term potential risk.
3. I am allergic to Advair (unable to digest the lactose based carrier), to get the LABA & steroid I have to take them separately.
The god damned FDA Panel has no right to limit or deny me this legal medicine that can save my life.
The FDA panel should NOT make decisions about how to deliver the drugs (separately or together.) If the LABA is legal in Advair, then it is legal. Denying the use in other (competitive) medicines is dicriminatory, increases the risks to my life, and raises the prices. It is also illegal for Advair to have a monopoly- even if the FDA created it.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
