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Physician Disempowerment:
A Transatlantic Malaise
Edited By: Peter J. Pitts
Download the E-Book Version Here
A Transatlantic Malaise
Edited By: Peter J. Pitts
Download the E-Book Version Here
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BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
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Pharma Marketing Blog
Pharmablogger
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Pharmalot
Pharmaceutical Business Review
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Prescription for a Cure
Public Plan Facts
Quackwatch
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Remedyhealthcare
Shark Report
Shearlings Got Plowed
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DrugWonks Blog
03/25/2008 06:28 AM |
In CMPI’s new paper, “The Hazards of Harassing Doctors:Regulation and Reaction in Trans-Atlantic Healthcare," Dr. Alphonse Crespo, a Swiss physician, points out that focusing on cost-savings rather than patient care has unintended – but highly predictable consequences:
“Obsession with cost-containment has brought about regulatory measures that significantly affect the independence of German doctors. The “Drugs Saving Package†voted by the German parliament, introduces penalties for prescription of “expensive†drugs and rewards physicians who restrict their prescriptions to low-cost copy generics. This ethically objectionable legal gimmickry - akin to bribing physicians not to treat to the best of their ability - was one of the sparks of the doctor protest movement. A recent survey suggests that 65% of German physicians condemn bureaucratic tampering with prescriptions. Public perceptions echo their concerns. Questioned on this issue, 60% of people at large reckon that they will no longer get the best possible treatment from their doctors. Judging by media coverage, most Germans sympathize with their doctors' plight but express scepticism as to their ability to influence government health care policy and budgeting.â€
Dr. Crespo’s complete essay and the complete paper can be found under the “Reports†heading at http://www.cmpi.org. Read More & Comment...
“Obsession with cost-containment has brought about regulatory measures that significantly affect the independence of German doctors. The “Drugs Saving Package†voted by the German parliament, introduces penalties for prescription of “expensive†drugs and rewards physicians who restrict their prescriptions to low-cost copy generics. This ethically objectionable legal gimmickry - akin to bribing physicians not to treat to the best of their ability - was one of the sparks of the doctor protest movement. A recent survey suggests that 65% of German physicians condemn bureaucratic tampering with prescriptions. Public perceptions echo their concerns. Questioned on this issue, 60% of people at large reckon that they will no longer get the best possible treatment from their doctors. Judging by media coverage, most Germans sympathize with their doctors' plight but express scepticism as to their ability to influence government health care policy and budgeting.â€
Dr. Crespo’s complete essay and the complete paper can be found under the “Reports†heading at http://www.cmpi.org. Read More & Comment...
03/24/2008 10:38 AM |
How can the WSJ run a piece on using genetics to redirect failed medicines to smaller groups of patients that are high responders and then engage in an orgy of second guessing about Vytorin? The Vytorin case is a clear example of seeking ways to personalize medicine and stratifying statin therapy according to particular pathways...but the thirst for headlines trumps science-based reporting.
http://online.wsj.com/article/SB120632582431058683.html?mod=home_health_right
DItto FiercePharma's continuing fearmongering on SSRIs.... It cites an "expert" who claims "People might have realized that the claims being made for the drug were overblown and coy to the point of being fraudulent."
But the "expert" is none other than David Healy, whose flawed study about SSRI's and suicide triggered a series of events which lead to less SSRI use and more suicide. And Healy makes millions shilling for trial attorneys as an expert witness.
Some expert. Some reporting.
http://www.iht.com/articles/ap/2008/03/24/europe/EU-MED-Drug-Data-Laws.php
http://www.fiercepharma.com/story/could-full-data-disclosure-avert-scandal/2008-03-24?utm_medium=nl&utm_source=link Read More & Comment...
http://online.wsj.com/article/SB120632582431058683.html?mod=home_health_right
DItto FiercePharma's continuing fearmongering on SSRIs.... It cites an "expert" who claims "People might have realized that the claims being made for the drug were overblown and coy to the point of being fraudulent."
But the "expert" is none other than David Healy, whose flawed study about SSRI's and suicide triggered a series of events which lead to less SSRI use and more suicide. And Healy makes millions shilling for trial attorneys as an expert witness.
Some expert. Some reporting.
http://www.iht.com/articles/ap/2008/03/24/europe/EU-MED-Drug-Data-Laws.php
http://www.fiercepharma.com/story/could-full-data-disclosure-avert-scandal/2008-03-24?utm_medium=nl&utm_source=link Read More & Comment...
03/24/2008 07:38 AM |
Interesting article in today’s Wall Street Journal on the use of genetic tools to resuscitate failed compounds.
Here how the story begins:
“As pharmaceutical makers find it increasingly difficult to bring new drugs to market, they are turning to genetic tools to seek uses for medicines that failed to make it out of the development pipeline.
The discovery of new links between genes and diseases can help not only to design new treatments, but to salvage drugs that are shelved when they come up short in clinical trials.â€
And here’s the rest of the story:
http://online.wsj.com/article/SB120631682077958247.html?mod=dist_smartbrief
The better understanding of genetic tools (via a robust collaboration of industry, academia, and government) will both expedite failure (which lowers the cost of R&D) and provide a broader spectrum for success (which rewards it).
Sound familiar? Correct – the Critical Path. Read More & Comment...
Here how the story begins:
“As pharmaceutical makers find it increasingly difficult to bring new drugs to market, they are turning to genetic tools to seek uses for medicines that failed to make it out of the development pipeline.
The discovery of new links between genes and diseases can help not only to design new treatments, but to salvage drugs that are shelved when they come up short in clinical trials.â€
And here’s the rest of the story:
http://online.wsj.com/article/SB120631682077958247.html?mod=dist_smartbrief
The better understanding of genetic tools (via a robust collaboration of industry, academia, and government) will both expedite failure (which lowers the cost of R&D) and provide a broader spectrum for success (which rewards it).
Sound familiar? Correct – the Critical Path. Read More & Comment...
03/24/2008 06:05 AM |
Our regulatory cousins to the north have begun the process of creating a biosimilar regulatory framework.
Health Canada recently posted on its website a draft guidance containing requirements for sponsors seeking to submit applications for “subsequent-entry biologics†once patents on biologic products start to expire. The agency says it could approve subsequent-entry products under existing drug regulations until laws are amended to include the new approval pathway.
Were the draft to become final, a subsequent-entry biologic sponsor would have to show that its proposed product is similar to a previously approved biologic, relying in part on publicly available safety and efficacy data. Interchangeability and substitutability would not be automatic but would be decided on a case-by-case basis, according to the draft guidance. Health Canada says it plans to publish additional guidance documents on specific product classes.
A subsequent-entry biologic would not automatically be approved for all the same indications as the reference product, and data would be required to support each indication in most cases. A subsequent-entry biologic also would have a product monograph different from that of the reference product. Read More & Comment...
Health Canada recently posted on its website a draft guidance containing requirements for sponsors seeking to submit applications for “subsequent-entry biologics†once patents on biologic products start to expire. The agency says it could approve subsequent-entry products under existing drug regulations until laws are amended to include the new approval pathway.
Were the draft to become final, a subsequent-entry biologic sponsor would have to show that its proposed product is similar to a previously approved biologic, relying in part on publicly available safety and efficacy data. Interchangeability and substitutability would not be automatic but would be decided on a case-by-case basis, according to the draft guidance. Health Canada says it plans to publish additional guidance documents on specific product classes.
A subsequent-entry biologic would not automatically be approved for all the same indications as the reference product, and data would be required to support each indication in most cases. A subsequent-entry biologic also would have a product monograph different from that of the reference product. Read More & Comment...
03/21/2008 06:08 AM |
Two interesting reader comments on the issue of government-sponsored counter-detailing as discussed in yesterday's blog entry "Close(d) Encounters."
Names have been withheld to protect the intelligent:
Dear DrugWonks:
What I think is interesting is whether this will become part of P4P proposals. If the government funds these counter-detailers, what happens if a physician refuses to see them? Are they reported to CMS? Are there repercussions for those physicians? Will they get more reimbursement if they see the government counter-detailers? If generic prescribing habits are part of P4P, as some propose, will this be part of it as well. Interesting to think about.
Dear DrugWonks:
I’d want to make sure the gov't detailers have to go by the same rules as the Rx companies -- FDA approved claims, FDA approved materials, no off label etc. Isn’t more info good?
PS, good luck getting a gov't employee to get in to see a doctor without pens and pizza if they don’t have cutting edge science to share
And if pharma detailers drive up the cost of Rx, won’t their detailers do the same? Read More & Comment...
Names have been withheld to protect the intelligent:
Dear DrugWonks:
What I think is interesting is whether this will become part of P4P proposals. If the government funds these counter-detailers, what happens if a physician refuses to see them? Are they reported to CMS? Are there repercussions for those physicians? Will they get more reimbursement if they see the government counter-detailers? If generic prescribing habits are part of P4P, as some propose, will this be part of it as well. Interesting to think about.
Dear DrugWonks:
I’d want to make sure the gov't detailers have to go by the same rules as the Rx companies -- FDA approved claims, FDA approved materials, no off label etc. Isn’t more info good?
PS, good luck getting a gov't employee to get in to see a doctor without pens and pizza if they don’t have cutting edge science to share
And if pharma detailers drive up the cost of Rx, won’t their detailers do the same? Read More & Comment...
03/21/2008 05:06 AM |
For those in Soros/Essential Action camp who fervently believe the way to develop drugs for global health is to have the government coordinate and run trials with IP seized from private companies, the latest HIV vaccine failures underscore the ideologically riven fecklessness of their position.
The notion that prizes to investigators plus a pittance to those who develop and manufacture medicines under a government-run clinical trial operation will yield breakthroughs is naive: the risky part, the hard part, the part requiring hundreds of billions of dollars a year, is development. That is why commercialization is critical to medical progress, as are profits.
The Soros/Essential Action model is based on hatred of capitalism not science. And in the end, it will doom the dying around the world to continued suffering. The groups will have their press clippings and accolades from the Left and those in need of breakthroughs will have nothing. Such is the perverted definition of "progress" advanced by George Soros and Essential Action Read More & Comment...
The notion that prizes to investigators plus a pittance to those who develop and manufacture medicines under a government-run clinical trial operation will yield breakthroughs is naive: the risky part, the hard part, the part requiring hundreds of billions of dollars a year, is development. That is why commercialization is critical to medical progress, as are profits.
The Soros/Essential Action model is based on hatred of capitalism not science. And in the end, it will doom the dying around the world to continued suffering. The groups will have their press clippings and accolades from the Left and those in need of breakthroughs will have nothing. Such is the perverted definition of "progress" advanced by George Soros and Essential Action Read More & Comment...
03/20/2008 02:14 PM |
Did you see the house editorial in today’s New York Times, “Countering the Drug Salesmen�
Here’s the link:
http://www.nytimes.com/2008/03/20/opinion/20thu2.html?_r=1&ref=opinion&oref=slogin
The editorial supports planned legislation by Senators Herb Kohl, Democrat of Wisconsin, and Richard Durbin, Democrat of Illinois that would authorize federal grants to prepare “objective†educational materials designed to provide physicians with “unbiased†guidance on the safety and effectiveness of drugs. Such materials, along with a government-funded “counter-detailing†force are meant to offset the one-sided sales pitches America’s physicians get from pharmaceutical company representatives. The Times believes that, “The end result should be better care, quite often at lower cost.â€
The Times shares the hope of Senators Kohl and Durbin that this government-funded scheme “would pay for itself by lowering drug costs to federal programs.â€
Perhaps, but at what cost to patient care? And what about the fact that “unbiased†and “objective†are in the eyes of the beholder?
Clearly pharmaceutical companies detail because they believe it is in the interest of both the public health and their own commercial imperatives. Nothing wrong with that. Self-interest and public interest are not mutually exclusive.
But it’s only honest to point out that the government has significant self-interest too – Uncle Sam is the largest “payer†in the nation. So the more drugs these government-funded workers classify as "wasteful," the more money the government saves. Such a conflict is hardly" unbiased.â€
Ultimately, as the European model has shown time and again, budget analysts and Big Brother-funded anti-pharmaceutical “truth squads†will deliver the findings their “funders†wants to see -- that newer, pricier pills are no more effective than their older, cheaper counterparts. And the result will be the same as well -- Medicare, Medicaid, and the Department of Veterans Affairs will stop covering these more innovative medicines, forcing physicians to prescribe only the drugs that the government will pay for, not the ones that are best for patients.
That’s what “government†care really delivers. Read More & Comment...
Here’s the link:
http://www.nytimes.com/2008/03/20/opinion/20thu2.html?_r=1&ref=opinion&oref=slogin
The editorial supports planned legislation by Senators Herb Kohl, Democrat of Wisconsin, and Richard Durbin, Democrat of Illinois that would authorize federal grants to prepare “objective†educational materials designed to provide physicians with “unbiased†guidance on the safety and effectiveness of drugs. Such materials, along with a government-funded “counter-detailing†force are meant to offset the one-sided sales pitches America’s physicians get from pharmaceutical company representatives. The Times believes that, “The end result should be better care, quite often at lower cost.â€
The Times shares the hope of Senators Kohl and Durbin that this government-funded scheme “would pay for itself by lowering drug costs to federal programs.â€
Perhaps, but at what cost to patient care? And what about the fact that “unbiased†and “objective†are in the eyes of the beholder?
Clearly pharmaceutical companies detail because they believe it is in the interest of both the public health and their own commercial imperatives. Nothing wrong with that. Self-interest and public interest are not mutually exclusive.
But it’s only honest to point out that the government has significant self-interest too – Uncle Sam is the largest “payer†in the nation. So the more drugs these government-funded workers classify as "wasteful," the more money the government saves. Such a conflict is hardly" unbiased.â€
Ultimately, as the European model has shown time and again, budget analysts and Big Brother-funded anti-pharmaceutical “truth squads†will deliver the findings their “funders†wants to see -- that newer, pricier pills are no more effective than their older, cheaper counterparts. And the result will be the same as well -- Medicare, Medicaid, and the Department of Veterans Affairs will stop covering these more innovative medicines, forcing physicians to prescribe only the drugs that the government will pay for, not the ones that are best for patients.
That’s what “government†care really delivers. Read More & Comment...
03/20/2008 06:16 AM |
Check out H.R. 5605, the “Physicians Payments Sunshine Act of 2008. The sponsor is Peter DeFazio (D-OR) and one of the co-sponsors is Pete Stark (D-CA). Here's a link to the proposed legislation:
Download file
(Another of the co-sponsors is Representative Dennis Kucinich – glad he’s getting back to work after the grueling primary season.)
The bill calls for the reporting of absolutely everything (and they thought of everything) over $25.00 considered “a transfer of value†to a physician.
(What’s the AWP for a large pizza and a liter of Diet Coke these days?)
The penalties are between $10,000 - $100,000 and multiple offenders can say adios to their corporate deductions for advertising related expenses.
According to Mr. Stark, “The Sunshine Act will help enable Medicare beneficiaries to determine if their doctors are acting in patients’ best interests. It may even convince doctors to quit taking what can only be described as industry kickbacks."
Kickbacks? That’s a pretty strong accusation. Mr. Stark should apologize to America’s physicians and to the pharmaceutical industry he slanders so easily. And as far as America’s Medicare beneficiaries, Mr. Stark might also want to mention that the Medicare Drug Benefit (Part D) doesn’t "pay" doctors.
Mr. DeFazio issued some equally thoughtful and measured comments:
"If the billions of dollars drug companies spend taking doctors on trips to the Caribbean and to expensive dinners at the country’s finest restaurants are above-board, then the pharmaceutical industry should support our legislation. This bill will keep the pharmaceutical industry honest."
Speaking of “honesty,†Mr. DeFazio should own up to the fact that the aforementioned boondoggle trips and are against the rules.
But this has nothing to do with honesty and everything to do with posturing – and hidden agendas. (One of the groups supporting this legislation is Consumers Union – yes, the same organization that receives millions of dollars from foundations supported by the generic drug industry.)
The concept that big bad Pharma is to blame for everything, and that a $25.15 pizza party is at the heart of the destruction of medical ethics, isn’t just simplistic and sophistic but deleterious to a serious conversation about the issue.
H. R. 5605 is just another example of superbity from our legislative Sultans of Sanctimony. Read More & Comment...
Download file
(Another of the co-sponsors is Representative Dennis Kucinich – glad he’s getting back to work after the grueling primary season.)
The bill calls for the reporting of absolutely everything (and they thought of everything) over $25.00 considered “a transfer of value†to a physician.
(What’s the AWP for a large pizza and a liter of Diet Coke these days?)
The penalties are between $10,000 - $100,000 and multiple offenders can say adios to their corporate deductions for advertising related expenses.
According to Mr. Stark, “The Sunshine Act will help enable Medicare beneficiaries to determine if their doctors are acting in patients’ best interests. It may even convince doctors to quit taking what can only be described as industry kickbacks."
Kickbacks? That’s a pretty strong accusation. Mr. Stark should apologize to America’s physicians and to the pharmaceutical industry he slanders so easily. And as far as America’s Medicare beneficiaries, Mr. Stark might also want to mention that the Medicare Drug Benefit (Part D) doesn’t "pay" doctors.
Mr. DeFazio issued some equally thoughtful and measured comments:
"If the billions of dollars drug companies spend taking doctors on trips to the Caribbean and to expensive dinners at the country’s finest restaurants are above-board, then the pharmaceutical industry should support our legislation. This bill will keep the pharmaceutical industry honest."
Speaking of “honesty,†Mr. DeFazio should own up to the fact that the aforementioned boondoggle trips and are against the rules.
But this has nothing to do with honesty and everything to do with posturing – and hidden agendas. (One of the groups supporting this legislation is Consumers Union – yes, the same organization that receives millions of dollars from foundations supported by the generic drug industry.)
The concept that big bad Pharma is to blame for everything, and that a $25.15 pizza party is at the heart of the destruction of medical ethics, isn’t just simplistic and sophistic but deleterious to a serious conversation about the issue.
H. R. 5605 is just another example of superbity from our legislative Sultans of Sanctimony. Read More & Comment...
03/19/2008 07:10 AM |
The Center for Medicine in the Public Interest will shortly publish a series of essays on the consequences of physican disempowerment in both the US and the EU. The title of this collection is "The Hazards of Harassing Doctors," and features contributions by Dr. Alphonse Crespo (a Swiss physician) and Dr. Marc Siegel (an American).
The thoughtful introduction is penned by Dr. Fred Goodwin, CMPI board member and Research Professor of Psychiatry at The George Washington University and Director of the University’s Center on Neuroscience, Medical Progress, and Society. Dr. Goodwin is the former Director of the National Institute of Mental Health
Here is a taste of Dr. Goodwin's take on the situation.
William Osler, generally regarded as the father of modern medicine wrote "If you listen carefully to the patient they will tell you the diagnosis." Arriving at a diagnosis and appropriate treatment plan has always represented collaboration between individual patients and their personal physician.
But today physicians are increasingly seeing the decisions that they and their individual patient reach about a specific treatment plan second guessed by distant “third parties†(working for government or insurance bureaucracies) who, of course do not –indeed cannot- know the physician or the unique individual circumstances of a particular patient. Lacking any knowledge of the patient or the doctor, these bureaucrats must fall back on general “guidelines†as the basis for approval or rejection of a particular treatment. Having served on guideline development bodies I can tell you that, at best, they represent the kind of “lowest common denominator†conclusions necessary to get the many different opinions represented on a committee to coalesce into a consensus. At worst guidelines represent a deliberate effort to drive down the cost of treatment by emphasizing “one size fits all†treatment approaches. While the physician-patient relationship theoretically remains the fulcrum of good medical practice and medical progress, in reality it is rapidly being replaced – on both sides of the Atlantic – by guidelines.
This movement towards guideline-driven medicine to which access to healthcare and physician reimbursement is increasingly linked, is based on the assumption that variations in medical practice are not only wasteful, but also potentially dangerous. Eliminating variations in clinical practice, we are told, will increase quality and save billions that could be poured into covering more uninsured or increasing coverage. The key to standardizing treatments – and outcomes – therefore are guidelines based on a combination of retrospective analysis of randomized clinical trials and the results of large prospective studies that compare the cost and effectiveness of established treatments or drugs in certain disease areas.
I bring a special perspective to this subject because of my professional background. On the one hand I have been a practicing physician for nearly 40 years and during almost all of those 40 years I was medical researcher and policy maker at the National Institute of Mental Health (NIMH). Incidentally my long experience in a part time private practice came about as a consequence of government salaries at the time not being competitive with academia so that a private practice was allowed in order to retain talent.
I was director of NIMH during the health care reform efforts of the first Clinton administration and, as such, I participated in some high level meetings of groups that were part of the effort. It is now well known that the perspective of practicing physicians was not included in this health care reform effort and my involvement was as the government’s principal mental health official, not as a clinician. Indeed I doubt that any of the other participants in the meetings I attended even knew that outside of my government job I was a physician in the private practice of a medical specialty.
I present this history so that the reader can understand what I am about to say. The meetings I attended had a surreal “Alice in Wonderland†quality. Here were all of these intelligent, well educated, well intended professionals discussing meta-analyses of controlled clinical trials, outcomes research, etc, etc, and yet it seemed that that none of them really understood what clinical practice was all about – it’s about enormous individual differences even among patients with the same diagnosis, it’s about cross-over trials where the physician uses each individual patient as their own control, trying treatment B when treatment A isn’t working, etc, etc Today’s advocates for coercive guideline driven medicine (as opposed to guidelines which are advisory to the doctor and the patient) seem to be cut from the same cloth as the people I encountered on those committees in the early 90s, except that now the lure of saving money and increasing the profits of managed care companies provides a new level of passion and intensity to these efforts.
In Europe, doctors are limited by reimbursement patterns and practice guidelines designed to control costs. This trend is growing in the United States. Yet there is no evidence that limiting access based on reviews of clinical literature or large scales trials either improves outcomes or saves money. On the contrary, the outcomes evidence suggests that seeking to elimination variations in practice and prescribing is actually more costly and contributes to morbidity.
The practice guidelines themselves are not the problem, it is how they are applied and for what purpose. Voluntary guidelines provide the intelligent physician with a benchmark from which to mark a patient’s progress or the impact of prevention. I have been involved in the development of practice guidelines for the treatment of mental illness for nearly three decades. It is a given that by the time there are developed, the guidelines themselves are outdated as new clinical insights and biomedical discoveries inform and shape both diagnosis and prescribing. The rigid imposition of guidelines regarding what to prescribe and how to treat insure that doctors cannot tailor treatments to the patient or deliver the best care.
Finally, the emphasis on cost-containment undermines continuity of care. The recognition that someone with mental illness is twice as likely to suffer from heart disease, diabetes or hypertension reveals the interaction of disease pathways which themselves have been show to be highly individualized. The evidence-based medicine movement fails to incorporate such insights. Rather, by emphasizing studies that evaluate the treatment of one aspect of a particular disease in a vacuum, the EBM movement is contributing to fragmentation of care.
Clinical decision-making is becoming increasingly centralized and the domains of economists or physicians who crunch numbers but never practice medicine.
Watch this space for more excerpts from this new and timely publication. Read More & Comment...
The thoughtful introduction is penned by Dr. Fred Goodwin, CMPI board member and Research Professor of Psychiatry at The George Washington University and Director of the University’s Center on Neuroscience, Medical Progress, and Society. Dr. Goodwin is the former Director of the National Institute of Mental Health
Here is a taste of Dr. Goodwin's take on the situation.
William Osler, generally regarded as the father of modern medicine wrote "If you listen carefully to the patient they will tell you the diagnosis." Arriving at a diagnosis and appropriate treatment plan has always represented collaboration between individual patients and their personal physician.
But today physicians are increasingly seeing the decisions that they and their individual patient reach about a specific treatment plan second guessed by distant “third parties†(working for government or insurance bureaucracies) who, of course do not –indeed cannot- know the physician or the unique individual circumstances of a particular patient. Lacking any knowledge of the patient or the doctor, these bureaucrats must fall back on general “guidelines†as the basis for approval or rejection of a particular treatment. Having served on guideline development bodies I can tell you that, at best, they represent the kind of “lowest common denominator†conclusions necessary to get the many different opinions represented on a committee to coalesce into a consensus. At worst guidelines represent a deliberate effort to drive down the cost of treatment by emphasizing “one size fits all†treatment approaches. While the physician-patient relationship theoretically remains the fulcrum of good medical practice and medical progress, in reality it is rapidly being replaced – on both sides of the Atlantic – by guidelines.
This movement towards guideline-driven medicine to which access to healthcare and physician reimbursement is increasingly linked, is based on the assumption that variations in medical practice are not only wasteful, but also potentially dangerous. Eliminating variations in clinical practice, we are told, will increase quality and save billions that could be poured into covering more uninsured or increasing coverage. The key to standardizing treatments – and outcomes – therefore are guidelines based on a combination of retrospective analysis of randomized clinical trials and the results of large prospective studies that compare the cost and effectiveness of established treatments or drugs in certain disease areas.
I bring a special perspective to this subject because of my professional background. On the one hand I have been a practicing physician for nearly 40 years and during almost all of those 40 years I was medical researcher and policy maker at the National Institute of Mental Health (NIMH). Incidentally my long experience in a part time private practice came about as a consequence of government salaries at the time not being competitive with academia so that a private practice was allowed in order to retain talent.
I was director of NIMH during the health care reform efforts of the first Clinton administration and, as such, I participated in some high level meetings of groups that were part of the effort. It is now well known that the perspective of practicing physicians was not included in this health care reform effort and my involvement was as the government’s principal mental health official, not as a clinician. Indeed I doubt that any of the other participants in the meetings I attended even knew that outside of my government job I was a physician in the private practice of a medical specialty.
I present this history so that the reader can understand what I am about to say. The meetings I attended had a surreal “Alice in Wonderland†quality. Here were all of these intelligent, well educated, well intended professionals discussing meta-analyses of controlled clinical trials, outcomes research, etc, etc, and yet it seemed that that none of them really understood what clinical practice was all about – it’s about enormous individual differences even among patients with the same diagnosis, it’s about cross-over trials where the physician uses each individual patient as their own control, trying treatment B when treatment A isn’t working, etc, etc Today’s advocates for coercive guideline driven medicine (as opposed to guidelines which are advisory to the doctor and the patient) seem to be cut from the same cloth as the people I encountered on those committees in the early 90s, except that now the lure of saving money and increasing the profits of managed care companies provides a new level of passion and intensity to these efforts.
In Europe, doctors are limited by reimbursement patterns and practice guidelines designed to control costs. This trend is growing in the United States. Yet there is no evidence that limiting access based on reviews of clinical literature or large scales trials either improves outcomes or saves money. On the contrary, the outcomes evidence suggests that seeking to elimination variations in practice and prescribing is actually more costly and contributes to morbidity.
The practice guidelines themselves are not the problem, it is how they are applied and for what purpose. Voluntary guidelines provide the intelligent physician with a benchmark from which to mark a patient’s progress or the impact of prevention. I have been involved in the development of practice guidelines for the treatment of mental illness for nearly three decades. It is a given that by the time there are developed, the guidelines themselves are outdated as new clinical insights and biomedical discoveries inform and shape both diagnosis and prescribing. The rigid imposition of guidelines regarding what to prescribe and how to treat insure that doctors cannot tailor treatments to the patient or deliver the best care.
Finally, the emphasis on cost-containment undermines continuity of care. The recognition that someone with mental illness is twice as likely to suffer from heart disease, diabetes or hypertension reveals the interaction of disease pathways which themselves have been show to be highly individualized. The evidence-based medicine movement fails to incorporate such insights. Rather, by emphasizing studies that evaluate the treatment of one aspect of a particular disease in a vacuum, the EBM movement is contributing to fragmentation of care.
Clinical decision-making is becoming increasingly centralized and the domains of economists or physicians who crunch numbers but never practice medicine.
Watch this space for more excerpts from this new and timely publication. Read More & Comment...
03/18/2008 10:14 AM |
According to the RPM Report:
“FDA Commissioner Andrew von Eschenbach expressed rare public irritability last week at the American Enterprise Institute.
What brought an edge to the voice of the usually unflappable, on-message commissioner? He bristled at the suggestion that the re-appointment of Janet Woodcock to head of the Center for Drug Evaluation & Research represents an attempt to rebuild the old ways of running the agency’s drug regulatory operations."
“I do not see her going back to CDER as business as usual,†von Eschenbach shot back in response to a question from a reporter during a Q&A session. She “is going back as a very, very strong change agent, and we have mapped and discussed many of those changes that she is embarking upon.â€
Here’s the complete story:
http://therpmreport.com/Free/41678225-dbfe-4f3a-972e-c223f74843d8.aspx?utm_source=RPMel
Some more aggressive retorts from the Commissioner:
Just because she has a long tenure in FDA management and is can be termed an “insiderâ€, the commissioner said, “does not in any way, shape or form mean that she is not a change agent.â€
Woodcock offers “understanding of the historical perspective as well as the external realities that are now impacting upon the agency,†the commissioner says (see here). She is “absolutely, the most extraordinarily gifted and talented person to lead†change at CDER.
Give 'em hell Andy -- it's about time. Read More & Comment...
“FDA Commissioner Andrew von Eschenbach expressed rare public irritability last week at the American Enterprise Institute.
What brought an edge to the voice of the usually unflappable, on-message commissioner? He bristled at the suggestion that the re-appointment of Janet Woodcock to head of the Center for Drug Evaluation & Research represents an attempt to rebuild the old ways of running the agency’s drug regulatory operations."
“I do not see her going back to CDER as business as usual,†von Eschenbach shot back in response to a question from a reporter during a Q&A session. She “is going back as a very, very strong change agent, and we have mapped and discussed many of those changes that she is embarking upon.â€
Here’s the complete story:
http://therpmreport.com/Free/41678225-dbfe-4f3a-972e-c223f74843d8.aspx?utm_source=RPMel
Some more aggressive retorts from the Commissioner:
Just because she has a long tenure in FDA management and is can be termed an “insiderâ€, the commissioner said, “does not in any way, shape or form mean that she is not a change agent.â€
Woodcock offers “understanding of the historical perspective as well as the external realities that are now impacting upon the agency,†the commissioner says (see here). She is “absolutely, the most extraordinarily gifted and talented person to lead†change at CDER.
Give 'em hell Andy -- it's about time. Read More & Comment...
03/18/2008 09:48 AM |
New website that is.
Check it out at http://www.fda.gov
(We'll take FDA reform in any form.) Read More & Comment...
Check it out at http://www.fda.gov
(We'll take FDA reform in any form.) Read More & Comment...
03/18/2008 08:19 AM |
Here's Alan Greenspan on the economic models used by the Fed and the banking community that "justified" the deep exposure of some financial institutions in subprime mortgage instruments:
"The models used by the finance industry to determine risk and measure economic strength are too simple to fully account for human responses. We cannot hope to anticipate the specifics of future crises with any degree of confidence."
http://money.cnn.com/2008/03/17/news/economy/greenspan/index.htm?postversion=2008031707
Translation: the rational models of utility and discounting activities are outdated because they fail to capture rapid and wide variations in response to risk and uncertainty.
Similarly, comparative effectiveness research, complete with QALYs and the assumption that standardizing care will lead to lower costs and optimal health are essentially ersatz consumer welfare models based again on the "rational actor" view of economics. There is more variability in healthcare because valuations and value do not correspond to particular price but rather to individual perceptions of risk and uncertainty that are part and parcel of the effort to treat and prevent disease. The simple models developed to predict and shape human responses in the healthcare system will anticipate changes or outcomes with any accuracy. Nor have they.
We have come a long way from when the RAND experiment was conducted. Read More & Comment...
"The models used by the finance industry to determine risk and measure economic strength are too simple to fully account for human responses. We cannot hope to anticipate the specifics of future crises with any degree of confidence."
http://money.cnn.com/2008/03/17/news/economy/greenspan/index.htm?postversion=2008031707
Translation: the rational models of utility and discounting activities are outdated because they fail to capture rapid and wide variations in response to risk and uncertainty.
Similarly, comparative effectiveness research, complete with QALYs and the assumption that standardizing care will lead to lower costs and optimal health are essentially ersatz consumer welfare models based again on the "rational actor" view of economics. There is more variability in healthcare because valuations and value do not correspond to particular price but rather to individual perceptions of risk and uncertainty that are part and parcel of the effort to treat and prevent disease. The simple models developed to predict and shape human responses in the healthcare system will anticipate changes or outcomes with any accuracy. Nor have they.
We have come a long way from when the RAND experiment was conducted. Read More & Comment...
03/17/2008 12:15 PM |
A post on the wsj.com healthblog by Heather Won Tesoriero claims
"Late last night, a pair of congressmen introduced a bill aimed at creating a pathway for approval of generic biotech drugs.
Finally, you say. But, wait, there’s a catch, and it’s a big one. The legislation would also give brand-name biotech drugs an extra 14 1/2 years of patent protection. (Read a summary of the bill, or the complete text.) That almost defeats the purpose of establishing a route to market for generic biotech drugs, advocates for them say. "
Well I read the summary and the text and it sounds like someone is buying the generic trade group's spin on the patent protection. No one is getting 15 years of additional patent protection. Rather, it gives companies going forward 12 years of data exclusivity and 2.5 years of patent life that of course begins well before a biologic enters clinical trials. The wailing is part of a larger strategy by the generic trade group to argue for the right to challenge biologic patents early and get market exclusivity as generic firms receive if they do make a successful challenge. Wailing as in: "Waah! Innovators get solid patent protection so I can't start copying their products from day one...waah!!
I am sure the anti-capitalists who attack pharma and BIO will go wild...
http://blogs.wsj.com/health/2008/03/14/want-generic-biotech-you-might-wait-14-more-years/?mod=googlenews_wsj Read More & Comment...
"Late last night, a pair of congressmen introduced a bill aimed at creating a pathway for approval of generic biotech drugs.
Finally, you say. But, wait, there’s a catch, and it’s a big one. The legislation would also give brand-name biotech drugs an extra 14 1/2 years of patent protection. (Read a summary of the bill, or the complete text.) That almost defeats the purpose of establishing a route to market for generic biotech drugs, advocates for them say. "
Well I read the summary and the text and it sounds like someone is buying the generic trade group's spin on the patent protection. No one is getting 15 years of additional patent protection. Rather, it gives companies going forward 12 years of data exclusivity and 2.5 years of patent life that of course begins well before a biologic enters clinical trials. The wailing is part of a larger strategy by the generic trade group to argue for the right to challenge biologic patents early and get market exclusivity as generic firms receive if they do make a successful challenge. Wailing as in: "Waah! Innovators get solid patent protection so I can't start copying their products from day one...waah!!
I am sure the anti-capitalists who attack pharma and BIO will go wild...
http://blogs.wsj.com/health/2008/03/14/want-generic-biotech-you-might-wait-14-more-years/?mod=googlenews_wsj Read More & Comment...
03/17/2008 07:45 AM |
Those who think a comparative effectiveness institute will generate super savings by imposing standardization on clinical practice should read Benjamin Brewer's latest blog in the WSJ entitled "Uncertainty is My Co-Pilot"
http://online.wsj.com/article/SB120527311006228441.html?mod=djempersonal Read More & Comment...
http://online.wsj.com/article/SB120527311006228441.html?mod=djempersonal Read More & Comment...
03/17/2008 07:18 AM |
Two articles in the NY Times -- one about the discussion of off-label uses for Zyprexa and another accusing drug companies of launching meds at a higher dose than necessary -- are devoid of scientific context.
The failure to report on off-label uses without describing the process of arriving at them and the fact that most are the product of trying to solve a clinical problem is a consistent and glaring gap in reporting. And burying the science only empowers trial attorneys and federal prosecutors who are constantly prodded by Senator Grassley to use the threat of prosecution to shake down drug companies for settlement fees.
With respect to the allegation that Avastin, Herceptin, Cerazyme, etc., are overdosed on purpose is completely without merit. Dosing is -- by the nature of clinical trials -- one size fits all. Achieving an appropriate dose in the real world goes on all the time and hitting the right dose -- as the warfarin genetic labeling effort suggests -- is a matter of genetic variation and other factors that cannot be integrated into drug development. And consider this: in some instances changing the timing and dosing of certain drugs can be regarded as off-label use and therefore subject to prosecution and tort lawyer litigation.
When Avastin was being developed it's initial "failure" in early trials was -- according to Judah Folkman who pioneered angiogenesis drugs -- linked directly to the fact that the FDA wanted every patient to get the same dose even though he believed varying dosing to a number of criteria -- would have led to better and more precise outcomes.
Many drugs don't work in most people at the marketed dose. The failure of HMOs not to provide coverage of the most expensive and innovative medicines should have nothing to do with dosing. The right dose for the right patient at the right time for the best outcome is the goal of any doctor. The Critical Path leading to personalized medicine or tailored treatments reflects the commitment of companies and the FDA to move away from the one-size fits all approach.
The media continues to ignore the underlying science shaping medicine and it leads to the arrogant notion that prosecutors and policy analysts can strip doctors of their discretion about how to prescribe and use medicines to advance the health of their patients.
http://www.nytimes.com/2008/03/16/business/16gaucher.html?pagewanted=1&_r=1&ref=todayspaper
http://www.nytimes.com/2008/03/15/business/15drug.html?scp=1&sq=berenson&st=nyt Read More & Comment...
The failure to report on off-label uses without describing the process of arriving at them and the fact that most are the product of trying to solve a clinical problem is a consistent and glaring gap in reporting. And burying the science only empowers trial attorneys and federal prosecutors who are constantly prodded by Senator Grassley to use the threat of prosecution to shake down drug companies for settlement fees.
With respect to the allegation that Avastin, Herceptin, Cerazyme, etc., are overdosed on purpose is completely without merit. Dosing is -- by the nature of clinical trials -- one size fits all. Achieving an appropriate dose in the real world goes on all the time and hitting the right dose -- as the warfarin genetic labeling effort suggests -- is a matter of genetic variation and other factors that cannot be integrated into drug development. And consider this: in some instances changing the timing and dosing of certain drugs can be regarded as off-label use and therefore subject to prosecution and tort lawyer litigation.
When Avastin was being developed it's initial "failure" in early trials was -- according to Judah Folkman who pioneered angiogenesis drugs -- linked directly to the fact that the FDA wanted every patient to get the same dose even though he believed varying dosing to a number of criteria -- would have led to better and more precise outcomes.
Many drugs don't work in most people at the marketed dose. The failure of HMOs not to provide coverage of the most expensive and innovative medicines should have nothing to do with dosing. The right dose for the right patient at the right time for the best outcome is the goal of any doctor. The Critical Path leading to personalized medicine or tailored treatments reflects the commitment of companies and the FDA to move away from the one-size fits all approach.
The media continues to ignore the underlying science shaping medicine and it leads to the arrogant notion that prosecutors and policy analysts can strip doctors of their discretion about how to prescribe and use medicines to advance the health of their patients.
http://www.nytimes.com/2008/03/16/business/16gaucher.html?pagewanted=1&_r=1&ref=todayspaper
http://www.nytimes.com/2008/03/15/business/15drug.html?scp=1&sq=berenson&st=nyt Read More & Comment...
03/17/2008 06:51 AM |
Last August I commented on the Lou Dobbs program that it was unlikely that Congress would take FDA reform seriously “until there were dead bodies.â€
Unfortunately, I was right.
On Friday, in the shadows of tainted Heparin, the Senate passed a budget resolution to give the F.D.A. an additional $375 million, a 20 percent increase over this year.
Some representative quotes on this issue from an article by Gardiner Harris in today’s edition of the New York Times:
“Congress has a responsibility to close the glaring gaps in food and drug safety that have begun to overwhelm the F.D.A.,†Senator Edward M. Kennedy, Democrat of Massachusetts.
“F.D.A. needs a serious infusion of resources and strong leadership dedicated to reforming the agency,†said Representative Henry A. Waxman, Democrat of California.
And, of course, everyone’s favorite FDA expert, Representative Rosa DeLauro, Democrat of Connecticut, “I don’t want to throw money at an agency that doesn’t have the infrastructure to carry out its mission.â€
Some top agency officials are simply “incompetent,†she added, and real change can occur only with a new administration.
Really, a new administration? Note to Representative DeLauro – the head of every center at the FDA is a career government employee. At the FDA, an agency of roughly 10,000, there are fewer than 10 “political†appointees. Does Ms. DeLauro, the chair of the House appropriations subcommittee with authority over the agency, believe that Dr. Janet Woodcock is “incompetent?†What about CBER’s Dr. Jesse Goodman – widely considered one of the finest scientists in government?
And then, of course, there’s the usual ranting from our favorite Sheep in Wolfe’s Clothing.
Here’s a link to the complete article:
http://www.nytimes.com/2008/03/17/health/policy/17fda.html?scp=2&sq=gardiner+harris&st=nyt
Alas, the title of the article says it all –“Tainted Drugs Put Focus on the F.D.A.â€
And it isn’t even a done deal. Read More & Comment...
Unfortunately, I was right.
On Friday, in the shadows of tainted Heparin, the Senate passed a budget resolution to give the F.D.A. an additional $375 million, a 20 percent increase over this year.
Some representative quotes on this issue from an article by Gardiner Harris in today’s edition of the New York Times:
“Congress has a responsibility to close the glaring gaps in food and drug safety that have begun to overwhelm the F.D.A.,†Senator Edward M. Kennedy, Democrat of Massachusetts.
“F.D.A. needs a serious infusion of resources and strong leadership dedicated to reforming the agency,†said Representative Henry A. Waxman, Democrat of California.
And, of course, everyone’s favorite FDA expert, Representative Rosa DeLauro, Democrat of Connecticut, “I don’t want to throw money at an agency that doesn’t have the infrastructure to carry out its mission.â€
Some top agency officials are simply “incompetent,†she added, and real change can occur only with a new administration.
Really, a new administration? Note to Representative DeLauro – the head of every center at the FDA is a career government employee. At the FDA, an agency of roughly 10,000, there are fewer than 10 “political†appointees. Does Ms. DeLauro, the chair of the House appropriations subcommittee with authority over the agency, believe that Dr. Janet Woodcock is “incompetent?†What about CBER’s Dr. Jesse Goodman – widely considered one of the finest scientists in government?
And then, of course, there’s the usual ranting from our favorite Sheep in Wolfe’s Clothing.
Here’s a link to the complete article:
http://www.nytimes.com/2008/03/17/health/policy/17fda.html?scp=2&sq=gardiner+harris&st=nyt
Alas, the title of the article says it all –“Tainted Drugs Put Focus on the F.D.A.â€
And it isn’t even a done deal. Read More & Comment...
03/14/2008 07:56 AM |
Here's a link to a a video that shows how atherosclerosis happens. This arterial tour gives you a graphic view of how unhealthy habit and genes can conspire to clog the major routes that supply blood to the heart and back again. No butter with your popcorn when watching this movie. Steve Nissen makes a cameo appearance as an avenging LDL molecule..(Not really.)
Read Full Story
Read More & Comment...
Read Full Story
Read More & Comment...
03/14/2008 05:25 AM |
The Center for Medicine in the Public Interest (the think tank home of drugwonks.com) is part of a transatlantic public policy institute consortium on the future of healthcare technology assessment (HTA). One of the member organizations, the German Institut fur Unternehmerische Freiheit (the Institute for Free Enterprise) held a seminar in Berlin yesterday entitled, "Cost Pressures on the German Health System -- Is Health Technology Assessment the Solution?"
One of the speakers was Dr. Christian Behles, Director and Professor of Drug Regulatory Affairs at the University of Bonn and an advisor to the German government.
Professor Behles pointed out that while IQWiG casts a suspicious eye on industry-designed pharmaco-economic studies, they use industry-sponsored RCTS as the basis of their comparative effectiveness findings.
He also noted that these RCTS were not designed to be used for head-to-head comparisons -- further reinforcing the recent comments made by NICE's Sir Michael Rawlings in front of the British House of Commons that HTA "is not based on empirical research."
In other words, IQWiG embraces industry-sponsored RCT data that was not designed to be used comparatively, while rejecting industry-sponsored data that was specifically designed to show the value of a new innovative medicine.
When is an industry study not an industry study? It seems that, for IQWiG, the answer is "when it's convenient."
It's interesting to note that the title of Professor Behles' presentation was, "HTA and Political Interference -- the Case of Germany's IQWiG." Read More & Comment...
One of the speakers was Dr. Christian Behles, Director and Professor of Drug Regulatory Affairs at the University of Bonn and an advisor to the German government.
Professor Behles pointed out that while IQWiG casts a suspicious eye on industry-designed pharmaco-economic studies, they use industry-sponsored RCTS as the basis of their comparative effectiveness findings.
He also noted that these RCTS were not designed to be used for head-to-head comparisons -- further reinforcing the recent comments made by NICE's Sir Michael Rawlings in front of the British House of Commons that HTA "is not based on empirical research."
In other words, IQWiG embraces industry-sponsored RCT data that was not designed to be used comparatively, while rejecting industry-sponsored data that was specifically designed to show the value of a new innovative medicine.
When is an industry study not an industry study? It seems that, for IQWiG, the answer is "when it's convenient."
It's interesting to note that the title of Professor Behles' presentation was, "HTA and Political Interference -- the Case of Germany's IQWiG." Read More & Comment...
03/13/2008 03:47 PM |
The best part of the ODAC meeting was when the committee as a whole dismissed Richard Padzur question -- designed to prop up an increasingly suspect coverage decision by CM -- asking to slap a one-size fits all dosing limit on ESAs. To quote one panelists: "This is silliness." Other comments could be characterized as dismissive.
In general the panel appeared perturbed that the FDA essentially did not provide it with either an objective or complete picture of the overall risks and benefits of ESA use in chemotherapy. The same goes with Padzur's lame attempt to misconstrue his negative opinion of the nature of quality of life data because most of it is observational study as the final word on the subject. He fooled the media who failed to look deeply into the data but not practicing oncologists on the panel.
Of course the media had all but predicted the demise of ESAs and is treating the ODAC decision as some sort of upset. Read the CNN.com piece below. You can just feel the shock and disappointment....Ultimately companies and doctors will have to work together to come up with more patient-centric data on who the drugs work for. If they had done this in the first place, the generalized concerns about safety could have been mitigated. Let's hope they do so going forward.
The committee did the right thing by swatting away Padzur's thinly veiled attemtp to manipulate them into affirming CMS' wrongheaded coverage decision. It did the right thing by giving doctors flexibility and recommending limiting use in areas where no benefit seems to exist.
http://money.cnn.com/2008/03/13/news/companies/amgen/?postversion=2008031316 Read More & Comment...
In general the panel appeared perturbed that the FDA essentially did not provide it with either an objective or complete picture of the overall risks and benefits of ESA use in chemotherapy. The same goes with Padzur's lame attempt to misconstrue his negative opinion of the nature of quality of life data because most of it is observational study as the final word on the subject. He fooled the media who failed to look deeply into the data but not practicing oncologists on the panel.
Of course the media had all but predicted the demise of ESAs and is treating the ODAC decision as some sort of upset. Read the CNN.com piece below. You can just feel the shock and disappointment....Ultimately companies and doctors will have to work together to come up with more patient-centric data on who the drugs work for. If they had done this in the first place, the generalized concerns about safety could have been mitigated. Let's hope they do so going forward.
The committee did the right thing by swatting away Padzur's thinly veiled attemtp to manipulate them into affirming CMS' wrongheaded coverage decision. It did the right thing by giving doctors flexibility and recommending limiting use in areas where no benefit seems to exist.
http://money.cnn.com/2008/03/13/news/companies/amgen/?postversion=2008031316 Read More & Comment...
03/13/2008 12:16 PM |
The committee voted against restricting the use of ESAs to small cell lung cancer.
Question 2--Should FDA require that product labeling be modified? Please address each of four potential approaches to mitigating risks through revised labeling separately.
a. To date, only clinical trials in small cell lung cancer have reasonably excluded an increased risk for death among patients receiving ESAs. Trials have demonstrated an increased risk of death and/or tumor promotion in head/neck, non-small cell lung cancer, breast (neoadjuvant and metastatic settings), lymphoid malignancies, and cervical cancers. Tumor types, other than those listed above, have not been adequately studied. Should the current indication be modified to restrict use only to patients with small cell lung cancer?
Vote: YES-- 6 NO-- 8
Question 2--Should FDA require that product labeling be modified? Please address the following potential approaches to mitigating risks through revised labeling.
b. Vote: The PREPARE trial demonstrated decreased relapse-free and overall survival in breast cancer patients receiving neoadjuvant chemotherapy. The risk/benefit assessment is different for patients receiving neoadjuvant and adjuvant chemotherapies than for patients with metastatic or incurable cancers. Should the current indication be modified to include a statement that ESA use is not indicated for patients receiving potentially curative treatments?
Vote: YES--11 NO--2
The current indication should be modified to say that it should not be used in the adjuvant setting.
c. Vote: Although increased tumor promotion and/or decreased survival have been demonstrated in several tumor types, adverse findings have been duplicated in two malignancies-breast cancer and head and neck cancer Should the current indication be modified to include a statement that ESA use is not indicated for patients with breast and/or head & neck cancers? (If yes, please specify breast and/or head & neck cancer).
Vote: YES--9 NO--5
Modified to say that ESA use not indicated for metastatic breast and head and neck cancers. Read More & Comment...
Question 2--Should FDA require that product labeling be modified? Please address each of four potential approaches to mitigating risks through revised labeling separately.
a. To date, only clinical trials in small cell lung cancer have reasonably excluded an increased risk for death among patients receiving ESAs. Trials have demonstrated an increased risk of death and/or tumor promotion in head/neck, non-small cell lung cancer, breast (neoadjuvant and metastatic settings), lymphoid malignancies, and cervical cancers. Tumor types, other than those listed above, have not been adequately studied. Should the current indication be modified to restrict use only to patients with small cell lung cancer?
Vote: YES-- 6 NO-- 8
Question 2--Should FDA require that product labeling be modified? Please address the following potential approaches to mitigating risks through revised labeling.
b. Vote: The PREPARE trial demonstrated decreased relapse-free and overall survival in breast cancer patients receiving neoadjuvant chemotherapy. The risk/benefit assessment is different for patients receiving neoadjuvant and adjuvant chemotherapies than for patients with metastatic or incurable cancers. Should the current indication be modified to include a statement that ESA use is not indicated for patients receiving potentially curative treatments?
Vote: YES--11 NO--2
The current indication should be modified to say that it should not be used in the adjuvant setting.
c. Vote: Although increased tumor promotion and/or decreased survival have been demonstrated in several tumor types, adverse findings have been duplicated in two malignancies-breast cancer and head and neck cancer Should the current indication be modified to include a statement that ESA use is not indicated for patients with breast and/or head & neck cancers? (If yes, please specify breast and/or head & neck cancer).
Vote: YES--9 NO--5
Modified to say that ESA use not indicated for metastatic breast and head and neck cancers. Read More & Comment...
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