Latest Drugwonks' Blog
“President Bush leaves office with a health care legacy in bricks and mortar: he has doubled federal financing for community health centers, enabling the creation or expansion of 1,297 clinics in medically underserved areas.”
Says who? The New York Times. (Ergo, it must be true.) The article, “Expansion of Clinics Shapes a Bush Legacy.” All the news that’s fit to print? Well almost. It’s pretty amazing that the Gray Lady opted to leave out any mention of Part D in the President's legacy. But maybe that article’s on the way.
But to give credit where credit is do, it’s a good article that raises some important questions -- one of the most important raised by House majority whip Representative James E. Clyburn (D, SC). Mr. Clyburn makes the very important point that reducing the number of uninsured will be meaningless if the newly insured cannot find medical homes.
This is a key policy point for many reasons, not the least of which is the successful management of chronic disease. Minus a warm and welcoming (and e-tized) medical home, we cannot seriously advance prevention initiatives (i.e., early detection) or improve our abysmal compliance/adherence rates. Minus a medical home we remain an acute care culture. Minus a medical home, even community health centers are but Potemkin villages.
Last year over 80,000 Americans had a foot amputated because of undiagnosed and untreated diabetes. Hundreds of thousands of heart attacks and strokes, caused by undiagnosed or untreated high blood pressure and high cholesterol, cost the American health care system billions of dollars a year while the cost in terms of human suffering cannot even begin to be measured.
Lack of early detection? Sure. Lack of compliance/adherence? Definitely. Lack of a medical home? Shameful.
When it comes to healthcare reform, we cannot leave patients home alone.
Says who? The New York Times. (Ergo, it must be true.) The article, “Expansion of Clinics Shapes a Bush Legacy.” All the news that’s fit to print? Well almost. It’s pretty amazing that the Gray Lady opted to leave out any mention of Part D in the President's legacy. But maybe that article’s on the way.
But to give credit where credit is do, it’s a good article that raises some important questions -- one of the most important raised by House majority whip Representative James E. Clyburn (D, SC). Mr. Clyburn makes the very important point that reducing the number of uninsured will be meaningless if the newly insured cannot find medical homes.
This is a key policy point for many reasons, not the least of which is the successful management of chronic disease. Minus a warm and welcoming (and e-tized) medical home, we cannot seriously advance prevention initiatives (i.e., early detection) or improve our abysmal compliance/adherence rates. Minus a medical home we remain an acute care culture. Minus a medical home, even community health centers are but Potemkin villages.
Last year over 80,000 Americans had a foot amputated because of undiagnosed and untreated diabetes. Hundreds of thousands of heart attacks and strokes, caused by undiagnosed or untreated high blood pressure and high cholesterol, cost the American health care system billions of dollars a year while the cost in terms of human suffering cannot even begin to be measured.
Lack of early detection? Sure. Lack of compliance/adherence? Definitely. Lack of a medical home? Shameful.
When it comes to healthcare reform, we cannot leave patients home alone.
When it comes to FDA reform, if you don't ask the right questions, you won't get the right answers.
It’s been widely reported this week that the FDA approved more “first-of-a-kind” drugs in 2008 (21) than it did in 2007 (18). During that same period fewer “black box” warnings (both new and updated) were awarded in 2008 (46) than in 2007 (62). What do these numbers mean?
To some (and you know who you are) they signal an agency that isn’t as concerned with safety as it was only twelve months earlier. More drugs approved? Fewer black boxes? And why, these same FDA watchers wonder, isn’t DDMAC sending out more warning and untitled letters to curb the abuses of pharmaceutical marketing – particularly of the off-label variety?
These are some of the questions they would ask. The media-friendly questions. The staff-prepared hearing questions. The trial lawyer questions. The politics before public health questions. The "tabloid medicine" questions. And they are the wrong questions.
For those who actually understand what’s going on there is a different set of queries altogether: Why did the FDA miss review deadlines for at least 15 drugs? Why are a growing number of complete response letters sounding more and more like the old-style not-approvable variety? And why are more and more complete response letters requesting information that was never discussed during the review process or at advisory committee meetings? Savvy pharmacenti also want to know what in Hell’s Bells is going on with “early safety” communications and signal-to-noise ratio issues.
But the big question those who know are asking is, Why is ambiguity trumping predictability in the regulatory process? This is the key issue that must be addressed by the new FDA Commissioner. That’s the question. The fear is Precautionary Principle creep. If the FDA adopts the position of doing nothing until it knows everything -- that will send a chilling message to the pharmaceutical industry to dial back R&D unless the program looks like a sure thing.
And there are no “sure things” in pharmaceutical discovery and development.
Industry seeks clarity. They want bright lines. They want to know the rules. They want predictability. This may sound simple and fair, but inside the FDA it has proven to be a fractious bureaucratic kulturkampf. “Change is not required,” as management guru W. Edwards Deming once said. “Survival is not mandatory.” And that doesn’t mean change for show, for politics – it means thoughtful, timely, strategic change that enhances the public health. And that kind of change requires not walking on egg shells – but breaking them. Andy von Eschenbach learned that the hard way.
Changing the minds of regulators to embrace bright lines rather than broad definitions is a challenging proposition -- because changed minds must begin with change agents. The new Commissioner must seek out and work with those career officials within the FDA who are smart, confident and gutsy enough to embrace new ways of doing business, who support bright lines over draft guidances, pragmatism over dogmatic doctrine. And those people are there and are excited about the possibilities of an FDA that will lead rather than an agency that buffets from side-to-side based on gusting political winds.
FDA’s Critical Path initiative is a promising example of the agency’s desire to embrace change. Going forward, the agency’s stakeholders will be looking for other “surrogate markers” to gauge FDA’s willingness to continue the McClellan era’s aggressive determination to both protect and advance the public health.
Despite new draft guidances that attempt to draw bright lines, what is and is not “in compliance” remains more art than science. Industry is confused, and the public health is not served. Predictability is power in pursuit of the public health. Predictability is the result of creative, forward-thinking leadership that rises above bureaucratic ambiguity. Driving this philosophy won’t be easy for the new Commissioner -- because swimming against the tide of an entrenched bureaucracy never is. But if the Commissioner communicates this philosophy, leads by doing and empowers change agents within the FDA career staff, the tide will turn.
As Winston Churchill said, “Ease is relative to the experience of the doer.”
It’s been widely reported this week that the FDA approved more “first-of-a-kind” drugs in 2008 (21) than it did in 2007 (18). During that same period fewer “black box” warnings (both new and updated) were awarded in 2008 (46) than in 2007 (62). What do these numbers mean?
To some (and you know who you are) they signal an agency that isn’t as concerned with safety as it was only twelve months earlier. More drugs approved? Fewer black boxes? And why, these same FDA watchers wonder, isn’t DDMAC sending out more warning and untitled letters to curb the abuses of pharmaceutical marketing – particularly of the off-label variety?
These are some of the questions they would ask. The media-friendly questions. The staff-prepared hearing questions. The trial lawyer questions. The politics before public health questions. The "tabloid medicine" questions. And they are the wrong questions.
For those who actually understand what’s going on there is a different set of queries altogether: Why did the FDA miss review deadlines for at least 15 drugs? Why are a growing number of complete response letters sounding more and more like the old-style not-approvable variety? And why are more and more complete response letters requesting information that was never discussed during the review process or at advisory committee meetings? Savvy pharmacenti also want to know what in Hell’s Bells is going on with “early safety” communications and signal-to-noise ratio issues.
But the big question those who know are asking is, Why is ambiguity trumping predictability in the regulatory process? This is the key issue that must be addressed by the new FDA Commissioner. That’s the question. The fear is Precautionary Principle creep. If the FDA adopts the position of doing nothing until it knows everything -- that will send a chilling message to the pharmaceutical industry to dial back R&D unless the program looks like a sure thing.
And there are no “sure things” in pharmaceutical discovery and development.
Industry seeks clarity. They want bright lines. They want to know the rules. They want predictability. This may sound simple and fair, but inside the FDA it has proven to be a fractious bureaucratic kulturkampf. “Change is not required,” as management guru W. Edwards Deming once said. “Survival is not mandatory.” And that doesn’t mean change for show, for politics – it means thoughtful, timely, strategic change that enhances the public health. And that kind of change requires not walking on egg shells – but breaking them. Andy von Eschenbach learned that the hard way.
Changing the minds of regulators to embrace bright lines rather than broad definitions is a challenging proposition -- because changed minds must begin with change agents. The new Commissioner must seek out and work with those career officials within the FDA who are smart, confident and gutsy enough to embrace new ways of doing business, who support bright lines over draft guidances, pragmatism over dogmatic doctrine. And those people are there and are excited about the possibilities of an FDA that will lead rather than an agency that buffets from side-to-side based on gusting political winds.
FDA’s Critical Path initiative is a promising example of the agency’s desire to embrace change. Going forward, the agency’s stakeholders will be looking for other “surrogate markers” to gauge FDA’s willingness to continue the McClellan era’s aggressive determination to both protect and advance the public health.
Despite new draft guidances that attempt to draw bright lines, what is and is not “in compliance” remains more art than science. Industry is confused, and the public health is not served. Predictability is power in pursuit of the public health. Predictability is the result of creative, forward-thinking leadership that rises above bureaucratic ambiguity. Driving this philosophy won’t be easy for the new Commissioner -- because swimming against the tide of an entrenched bureaucracy never is. But if the Commissioner communicates this philosophy, leads by doing and empowers change agents within the FDA career staff, the tide will turn.
As Winston Churchill said, “Ease is relative to the experience of the doer.”
Another study showing that certain drugs used in combination when we are old don't always mix well.
This on the heels of a NEJM study showing high and low responders among Plavix users based on genetics.
How long will it take HMOs to connect the dots, save lives and practice patient-centered medicine by using genetic testing on high risk populations?
This on the heels of a NEJM study showing high and low responders among Plavix users based on genetics.
How long will it take HMOs to connect the dots, save lives and practice patient-centered medicine by using genetic testing on high risk populations?
Interesting story in today’s New York Times on Tom Daschle’s call for “Healthcare House Parties.”
In typical New York Times fashion, the event they chose as an example was peopled mostly by Obama campaign volunteers (including one person who works at the NIH and another who is “active in women’s health advocacy”). So not your typical slice of America.
Nevertheless, some interesting tidbits.
For example, here’s what one party member had to say about a government-sponsored plan, “similar to Medicare,” that would compete with private insurance companies -- “A public insurance plan would not take anything away. It just adds another option.”
Options are good. But would a government plan compete fairly? Or would it ultimately drive private plans out of business by adopting, what in the free market world would be referred to as, a loss-leader strategy? And we all know what happens once that happens. A government run one-payer system that puts cost before care. Options are good. Naïvité is not.
And what might such a system cost? According to the Times story, “The Obama transition team did not ask people how a new health care system should be financed, but several people here said that individuals and businesses should have to pay a small health care tax — some preferred to call it a ‘contribution’ — so that everyone could be covered.”
That’s nice. A contribution. Like buying Girl Scout cookies. Well, not quite. Consider the facts:
In the United Kingdom, British citizens pay 11 to 12 percent of their weekly income to finance the country’s healthcare system. And in Canada about a fifth of taxes collected in Canada go toward funding the country’s health system. That's a lot of Thin Mints -- more than many Americans are willing to swallow.
In a recent poll of over a thousand 18 to 24 year-old Americans – the so-called “millennial” generation -- conducted by the Center for Medicine in the Public Interest (the public policy home of drugwonks.com), 62% said they would not support any reforms that could increase physician wait times or restrict access to new medical treatments. Nearly two-thirds said they would not support additional government interference in the doctor-patient decision-making process.
Precisely the result of government healthcare.
Oh, and a majority (51 percent) were not in support of any health care reforms that could raise their personal tax burden.
The Times reports that, The Obama transition team asked for ‘particularly poignant stories to highlight the need for health care reform,’ and such stories were abundant at the round table here.”
But can we afford healthcare reform by anecdote?
In typical New York Times fashion, the event they chose as an example was peopled mostly by Obama campaign volunteers (including one person who works at the NIH and another who is “active in women’s health advocacy”). So not your typical slice of America.
Nevertheless, some interesting tidbits.
For example, here’s what one party member had to say about a government-sponsored plan, “similar to Medicare,” that would compete with private insurance companies -- “A public insurance plan would not take anything away. It just adds another option.”
Options are good. But would a government plan compete fairly? Or would it ultimately drive private plans out of business by adopting, what in the free market world would be referred to as, a loss-leader strategy? And we all know what happens once that happens. A government run one-payer system that puts cost before care. Options are good. Naïvité is not.
And what might such a system cost? According to the Times story, “The Obama transition team did not ask people how a new health care system should be financed, but several people here said that individuals and businesses should have to pay a small health care tax — some preferred to call it a ‘contribution’ — so that everyone could be covered.”
That’s nice. A contribution. Like buying Girl Scout cookies. Well, not quite. Consider the facts:
In the United Kingdom, British citizens pay 11 to 12 percent of their weekly income to finance the country’s healthcare system. And in Canada about a fifth of taxes collected in Canada go toward funding the country’s health system. That's a lot of Thin Mints -- more than many Americans are willing to swallow.
In a recent poll of over a thousand 18 to 24 year-old Americans – the so-called “millennial” generation -- conducted by the Center for Medicine in the Public Interest (the public policy home of drugwonks.com), 62% said they would not support any reforms that could increase physician wait times or restrict access to new medical treatments. Nearly two-thirds said they would not support additional government interference in the doctor-patient decision-making process.
Precisely the result of government healthcare.
Oh, and a majority (51 percent) were not in support of any health care reforms that could raise their personal tax burden.
The Times reports that, The Obama transition team asked for ‘particularly poignant stories to highlight the need for health care reform,’ and such stories were abundant at the round table here.”
But can we afford healthcare reform by anecdote?
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.
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.
